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BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM; INTRODUCER, CATHETER
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| Model Number D138502 |
| Device Problems
Material Separation (1562); Contamination /Decontamination Problem (2895); Patient Device Interaction Problem (4001)
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| Patient Problem
Foreign Body In Patient (2687)
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| Event Date 08/08/2022 |
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Event Type
Injury
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Manufacturer Narrative
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The bwi product analysis lab received both photographs of the complaint device and the actual complaint device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Event Description
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It was reported that a 72-year-old male patient (81kgs) underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.The patient experienced plastic in the groin puncture.It was reported that when the physician pulled the vizigo from the groin after the procedure they noticed plastic hairs still in the groin puncture.The physician then cut into the vizigo to see inside the sheath and found more plastic hairs.The physician requested the vizigo be inspected.The physician¿s opinion on the cause of this event is that it was due to a bwi product malfunction: the sheath ¿delaminated.¿ no intervention was provided to the patient.Only item 3 from the photos remained in the wound and had to be removed.The rest were found inside the sheath.The plastic material was removed from the patient; it was pulled from the groin closure.Pictures been provided.The patient outcome of the event is fully recovered no perceivable adverse outcome.The patient did not require extended hospitalization because of the event.Product has been returned the physician did not feel/observe any resistance while introducing the dilator, the needle, or the catheter into the sheath.There was no damage observed in the dilator, the needle, or the catheter.Needle used was a 98 cm brk extra sharp.Stsf, pentarey caths were used.Foreign body is mdr-reportable.Foreign material on usable length of catheter is mdr-reportable.Hemostatic valve separation is mdr-reportable.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.
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Manufacturer Narrative
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On 31-aug-2022, bwi received additional information regarding the event.Clarification provided from the bwi sales consultant about the report that the sheath being "delaminated.¿ according to the bwi sales consultant the physician used that word, however, they are not sure if that¿s what actually happened.Essentially those plastic hairs came out of the sheath.They don¿t know if they were excess material from the manufacturing process or if they were scraped off of the inside.They did not see the layers of the sheath detaching from one another (ie: delaminating).The only internal components exposed were the plastic ¿hairs.¿ furher information was received on 8-sep-2022.The workflow has been confirmed: transseptal approach using vizigo; exchange to a pentaray dx; exchange to a stsf tx; closure and case complete.The entire procedure was done with no observations.No resistance, difficulty or any noted challenge or abnormality with the devices.When the procedure was completed, the sheath was removed.When the wound was being prepped for closure, it was at that point the fibers were detected in the groin area.It is reasonable to deduce at least some of the fiber was in the actual vein, but the majority reportedly outside the body which is what was detected.Th fiber was pulled free, and this is when the physician decided to cut open the sheath and look for additional fibers within the main lumen of vizigo.More fibers were found at that time.He then proceeded to check the patient to see if any such fibers were left in the body and when he was convinced that was not the case the wound was closed.In speaking with the bwi sales consultant, sheath ¿skiving¿ has been an issue in the past with the competitive agilis sheath at this site.Much care is taken locally to ensure that the stylet is used when manipulating the needle as a result.They inquired that when the dilator was advanced in the sheath prior to tsp with the needle (and stylet) inserted, if it was possible the needle was not completely inside the dilator leaving it exposed, the bwi sales consultant could not say for sure but stated that it could be possible.Another update occurred on 16-sep-2022.The visualization issues occurred during the procedure.The bwi sales consultant thought he remembered it as electrode 3.The electrodes are counted distal to proximal, 1 being the most distal.When there are issues the electrodes turn black on carto, and this was observed throughout the case.Obviously, the sheath kept working mechanically in this scenario.In this case, it is likely visualization will still work to a degree.The sheath may show striped which is a carto indication of reduced visualization accuracy which the site also reported seeing.Because of how the software works and how vizigo reacts in the constructed matrix, it is actually likely visualization would be working pretty well with electrode 3 having either intermittent connectivity or disconnected completely.Because the device still mechanically worked, and they had some visualization they just kept using it and finished the case.They experienced the electrodes turning black on the carto, as well as the ¿sheath showing as striped.¿ it was experienced early on in the procedure.---------------------------------------------- additionally, the product investigation was completed based on a received photograph of the device (1-sep-2022).A picture was received for evaluation following biosense webster's procedures.According to the picture provided by the customer, the hemostatic valve was dislodged inside the hub component.This issue could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve; however, this could not be conclusively determined.Also, the caller mentioned those plastic hairs were observed on the groin puncture, and according to the pictures it looks like magnetic wires (the wires are a different colors), however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device number 00002039 and no internal action related to the complaint was found during the review.The issue reported by the customer was confirmed based on the picture received.The device has not been returned for analysis and is not possible to assign a root cause based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly.The odp (optimal device performance guide) contains the following caution: always insert a dilator straight into the center of the sheath¿s valve to prevent damage to the valve.Do not insert a dilator at an angle, as damage to the sheath valve may occur.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Manufacturer Narrative
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On 11-jan-2023, the product investigation was completed.It was reported that a 72-year-old male patient (81kgs) underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.The patient experienced plastic in the groin puncture.It was reported that when the physician pulled the vizigo from the groin after the procedure they noticed plastic hairs still in the groin puncture.The physician then cut into the vizigo to see inside the sheath and found more plastic hairs.The physician requested the vizigo be inspected.Device evaluation details: visual analysis of the returned sample revealed the sheath was found cut in the proximal section near to handle.Additionally, some materials were received, plastic strips and green wires were found at the edge of the shaft cut.The valve was observed in correct position however, according the picture provided by the customer, the valve was observed dislodged.Clarification was requested to the customer and they cannot confirm if the picture is the device of this complaint.Samples were analyzed thru fourier transform infrared test (ftir) to determine the composition.The fiber 1 sample exhibited the chemical composition of polypropylene base material; and fibers 2 and 3 showed the base composition of polytetrafluoroethylene (ptfe) polymer.Additionally, unknown reddish material found adhered to fiber 3, exhibited the characteristic composition of a biologic-based material.Finally, green wire was analyzed thru scanning electron microscopy (sem) and it was concluded the following: the wire fund in the carto vizigo sheath is primarily composed of copper.This wire found could be correspond to an electrode wire.Therefore, the device was sent to supplier to perform an in deep investigation, with the next results: damage of this kind is not commonly seen within the process and has a high likelihood of being detected by the freudenberg medica process controls.The device would fail leak test and or fail borescope inspection if this condition was present or caused in the manufacturing process.The defect could not be reproduced in the freudenberg medical manufacturing process.Multiple attempts to reproduce damage by inserting various dilators, mandrels and processing aids into the inside diameter proved unsuccessful.Although the cause of this complaint is unknown it cannot be confirmed to be related or caused by the manufacturing process.It is believed that such damage to the shaft would require high force by a sharp object from the inside of the device potentially during use.Additionally, an escalation investigation was performed and determined that the material identified by the physician comes from the inner lumen of the vizigo¿ sheath.It was also determined that the needle that was used with the vizigo¿ sheath for the procedure was purposefully bent by the physician prior to the procedure.Through the investigation, it was concluded that when bending the needle in the same way that the physician bent the needle prior to the procedure, the internal damage to the vizigo¿ sheath was reproduced.If the needle is reshaped with a larger curve this will increase the forces applied by the tip of the needle as it is advanced through the dilator against the inner lumen, which in turn may increase the risk of skiving particles, in extreme cases it may puncture the sheath and dilator.Based on the additional information received and several replicas made by research and develop team, the preliminary root cause indicates that damage to the inner structure of a vizigo¿ sheath can occur when a physician alters the shape of a transeptal needle.A device history record review was performed for the finished device number 00002039, and no internal actions related to the complaint were found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Manufacturer Narrative
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A picture was received for evaluation following biosense webster's procedures.On 8-feb-2023, the photo analysis was completed.According to the picture provided by the customer, the hemostatic valve was dislodged inside the hub component.This issue could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve; however, this could not be conclusively determined.It was also mentioned that those plastic hairs were observed on the groin puncture, and according to the pictures it looks like magnetic wires (the wires are a different colors), however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device number 00002039 and no internal action related to the complaint was found during the review.The odp (optimal device performance guide) contains the following caution: always insert a dilator straight into the center of the sheath¿s valve to prevent damage to the valve.Do not insert a dilator at an angle, as damage to the sheath valve may occur.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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