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| Model Number 606-S272X |
| Device Problem
Contamination /Decontamination Problem (2895)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Product complaint: (b)(4).Date of event: the date of the event was not reported.The company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
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Event Description
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As reported by the field, at the end of the procedure, a prowler select plus 170/15 cm microcatheter ( 606s272x, 30858782) showed a gel-like substance at the proximal end of the hemostatic valve.There was no patient injury reported.In order to further investigate this matter, the customer had the prowler select plus microcatheter, the associated hemostatic valves, and a brand-new catheter examined in a suitable institute.Additional information received of the device involved concluded the following: the ft-ir spectra of the drying residues of the cloudy appearing liquids at the end of the valve of the used micro catheter show a significant accordance to the spectrum of the outer surface of the distal end as well as the one of the outer surface of the light blue coloured part of the unused catheter (p1).The spectra also show a significant accordance to database spectra of polyvinylpyrrolidone.The residues in the sample probably consist of polyvinylpyrrolidone.The ft-ir spectrum of the whitish particle in the liquid at the end of the valve of the sample shows a very high accordance to database spectra of different proteins.The particle is very likely formed by protein.
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Manufacturer Narrative
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Product complaint # (b)(4).Section b5: additional information was received indicating that after the observation of the foreign material in the rhvs, the user stopped using this catheter.A terumo guidewire was used without resistance while advancing through the hub prior to noticing the foreign material.Once the foreign material was observed, the user immediately disconnected the rhv from the guide catheter and aspirated 20 cc blood through the guide catheter.Complaint conclusion: as reported by the field, at the end of the procedure, a prowler select plus 170/15 cm microcatheter ( 606s272x, 30858782) showed a gel-like substance at the proximal end of the hemostatic valve.There was no patient injury reported.In order to further investigate this matter, the customer had the prowler select plus microcatheter, the associated hemostatic valves, and a brand-new catheter examined in a suitable institute.Additional information received of the device involved concluded the following: the ft-ir spectra of the drying residues of the cloudy appearing liquids at the end of the valve of the used micro catheter show a significant accordance to the spectrum of the outer surface of the distal end as well as the one of the outer surface of the light blue coloured part of the unused catheter (p1).The spectra also show a significant accordance to database spectra of polyvinylpyrrolidone.The residues in the sample probably consist of polyvinylpyrrolidone.The ft-ir spectrum of the whitish particle in the liquid at the end of the valve of the sample shows a very high accordance to database spectra of different proteins.The particle is very likely formed by protein.Additional information was received indicating that after the observation of the foreign material in the rhvs, the user stopped using this catheter.A terumo guidewire was used without resistance while advancing through the hub prior to noticing the foreign material.Once the foreign material was observed, the user immediately disconnected the rhv from the guide catheter and aspirated 20 cc blood through the guide catheter.A review of manufacturing documentation associated with this lot 30858782 presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Complaint history for prowler select product family found no similar findings on the last two years.The customer complaint was confirmed based on the foreign material observed in the pictures attached, as well as the ft-ir findings.This investigation was performed based only on the photo provided, however, since this issue was discovered at the end of the procedure, the most likely source of the foreign material observed must be the clinical setting.According to the information received, the customer is retaining the product, therefore, no further investigation can be conducted; should the device and the foreign material be received at a later time, this investigation will be re-assessed accordingly.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required at this time.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.
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Manufacturer Narrative
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Product complaint # (b)(4).Updated section on this medwatch report: b4, b5, g3, g6, h2, h3, h10 and concomitant products.Additional information was discussed with the physician and the medical safety officer via a conference call on 02-may-2023.The following was discussed: at the rhv there is a cloudy residue left behind when psp and rapidtransit catheters are withdrawn through valve.Highly reproducible and not observed in other catheters.Video was shared showing removal of rebar18 and trevo pro18, another video was shared with rapidtranist where residue is visible in rhv while retracting the catheter, and the same situation with a psp.In all cases the same merit rhv is used.The physician confirmed that the videos shown were taken in actual case with patient, at the end of procedure.It was confirmed that the wires used were the terumo synchro wire and portal 14 guidewire.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
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Manufacturer Narrative
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Product complaint (b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
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Manufacturer Narrative
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Product complaint #(b)(4).Research & development assessment: the prowler microcatheters (mc) have hydrophilic coating applied to the outside surface of the catheter from the distal tip for a length of 30 centimeters proximally.The hydrophilic coating is a liquid solution consisting of a polyvinyl pyrrolidone polymer in a solvent.The catheter is dipped into the coating solution, and subsequently oven cured.The possible ways for hydrophilic coating to be introduced into the internal lumen of the catheter are: coating introduced into the lumen during the coating process.Coating scraped from the exterior surface of the catheter and aspirated or transferred into the lumen during use.Coating scraped from the steerable guidewire as it is passed through the lumen of the mc.The factors affecting the likelihood of each of these events occurring is discussed below: there are controls in the manufacturing process to prevent the introduction of the coating into the lumen of the mc.The procedure includes a nitrogen purge during the coating application process and for an additional 30 seconds afterward while the catheter is shaken / twirled.The nitrogen flowing through the catheter prevents liquid from entering the lumen.After the catheter is coated, a stainless-steel mandrel is reinserted into the lumen prior to oven curing.If there is any resistance to the insertion of the mandrel, the part is rejected.The mandrel is 0.0207¿ od, which is very close fitting to the.021¿ lumen.The gap is 0.0003¿ or.008 mm.The likelihood for coating to be scraped from the external surface of the catheter and transferring it to the lumen is remote.The mc is connected to a continuous flush of saline throughout the procedure, preventing any coating from entering the tip of the mc.If the steerable guidewire delivered through the lumen of the mc contained hydrophilic coating, the friction of the rhv seal on the mc hub could scrape the coating from its external surface.During retraction of the guidewire, the coating would tend to accumulate in front of the gasket of the rhv, as was found in the complaint unit.A review of manufacturing documentation associated with this lot 30858782 presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Complaint history for prowler select product family found no similar findings on the last two years.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required at this time.The customer complaint was confirmed based on the foreign material observed in the pictures attached, as well as the ft-ir findings.This investigation was performed based only on the photo provided, however, since this issue was discovered at the end of the procedure, the most likely source of the foreign material observed must be the clinical setting.According to the information received, the customer is retaining the product, therefore, no further investigation can be conducted; should the device and the foreign material be received at a later time, this investigation will be re-assessed accordingly.Complaint trends are monitored on a monthly basis as part of the company post market surveillance.
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Manufacturer Narrative
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Product complaint(b)(4).A non-sterile prowler select plus 170/15 cm microcatheter was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and two (2) compressed conditions were observed at the distal end of the microcatheter; the first at 2 cm, and the second at 5.50 cm.Dried residues were observed on the luer hub of the microcatheter.The presence of hydrophilic coating on the microcatheter was tested by submerging the distal end of the device into water with food coloring.Damages were observed on portions of the microcatheter, as coating was noted not present.Fourier transform infrared spectroscopy (ftir) was performed on the residues found on the hemostasis valves, showing that the residues exhibited a representative absorption peak for amide, lipid and phosphate bands, concluding that the foreign material was primarily composed of a biological-base material.A second ftir was performed on the residues found on the hemostasis valves, the complaint microcatheter and a good lab sample catheter.The results of the ftir regarding the foreign material showed that the unknown residue in valve presented a consistent siloxane base material spectrum in all sampling points with small vibration peaks that can be associated to c-h stretching vibrations, along with polydimethylsiloxane (pdms).A rocking methyl vibration directly influenced by the vicinity of silicon on the adjacent atom/bond conjugation was also observed.The foreign material analyzed presents a biologic base material, while the hydrophilic coating showed the vibrations for pyrrolidone base material.In conclusion, no hydrophilic coating residues were found in the valve sample during the re-analysis, the pyrrolidone compound (from coating) infrared peaks were not observed in the sampling areas.Only a siloxane compound was found in all internal walls of the valve component.Source of origin of the siloxane material remains unknown.Comparison test between original contamination and hydrophilic coating, revealed that samples does not share the same infrared spectrum pattern, with a match of 32%.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The issue reported regarding the presence of a gel-like substance on the hemostasis valves was confirmed; however, further analysis indicated that the residues observed did not belong to a cerenovus device.The coating damages of the microcatheter are suspected to be the result of the device manipulation during further inspection performed by the third-party institute.With the limited information available, and evidence obtained from the inspection, there is no clear insight into the root cause and/or exact contributing factors that may have result in foreign material accumulation into the valves.The compressed conditions on the microcatheter were not originally reported by the customer, and these damages are suggested to be the result of the post-operative handling/inspection of the device.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damaged devices from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.
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Manufacturer Narrative
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Product complaint # (b)(4).The product analysis was updated as follows: the device was sent independently to an external laboratory for fourier transform infrared spectroscopy (ftir) analysis prior to send it to cerenovus, concluding the following: upon receiving the device, visual inspection was performed, and two (2) compressed conditions were observed at the distal end of the microcatheter; the first at 2 cm, and the second at 5.50 cm.The distal tip was elongated and flattened at the dark blue pellethane 80ae tubing section.Dried residues were observed on the luer hub of the microcatheter.The presence of hydrophilic coating on the microcatheter was tested by submerging 30 cm of the distal end of the device into water with food coloring and performing a visual inspection.Coating damage was observed on portions of the microcatheter.The damage varied along the coated length of the catheter and ranged from minimal to substantial.The coating removal was worse in the pellethane 65d light blue section of the catheter.The hemostasis valves were inspected under the microscope, and residues of a gel-like substance were observed along the entire length of the internal walls of the valves.Fourier transform infrared spectroscopy (ftir) was performed on the residues found on the hemostasis valves, showing that the residues exhibited a representative absorption peak for amide, lipid and phosphate bands, concluding that the foreign material was primarily composed of a biological-base material.A second ftir was performed on the residues found on the hemostasis valves, the complaint microcatheter and a good lab sample catheter.The results of the ftir regarding the foreign material showed that the unknown residue in valve presented a consistent siloxane base material spectrum in all sampling points with small vibration peaks that can be associated to c-h stretching vibrations, along with polydimethylsiloxane (pdms).A rocking methyl vibration directly influenced by the vicinity of silicon on the adjacent atom/bond conjugation was also observed.The foreign material analyzed presents a biologic base material, while the hydrophilic coating showed the vibrations for pyrrolidone base material.In conclusion, no hydrophilic coating residues were found in the valve sample during the re-analysis, the pyrrolidone compound (from coating) infrared peaks were not observed in the sampling areas.Only a siloxane compound was found in all internal walls of the valve component.The source of origin of the siloxane material remains unknown.A comparison test between original contamination and hydrophilic coating, revealed a poor match of 32% to the infrared coating spectrum of pvp.Since the hemostasis valves were not sealed when shipped to cerenovus from the physician¿s external lab, it assumed that any liquid containing the cloudy residue was either sampled completely for the outside analysis or was allowed to escape from inside of the valve.This may have made subsequent analysis difficult to verify the outside lab¿s findings.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The issue reported regarding the presence of a gel-like substance on the hemostasis valves was confirmed; however, further analysis indicated that the residues observed do not belong to a cerenovus device.The coating damage of the microcatheter are consistent with scraping of the coating while pulling the catheter through a closed hemostasis valve.The extended flattened sections seen on the microcatheter shaft are consistent with an external clamping force acting over an extended length of the catheter.Based on the pattern of coating removal from the catheter surface and the flattening of the softest sections of the catheter the root cause is determined to be coating removal by the rhv.The compressed conditions on the concomitant microcatheter were not originally reported by the customer, however, are most consistent with and most likely resulting from tightening the rhv to a level that exceeds the hoop strength of the catheter, which could also damage the coating.These compressed sections do not appear to be kinks which could occur during post-case handling.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damaged devices from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
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Search Alerts/Recalls
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