| Catalog Number IC71132CA |
| Device Problems
Break (1069); Fluid/Blood Leak (1250); Physical Resistance/Sticking (4012)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 07/02/2021 |
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Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as other in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.The company is seeking this information through the event investigation.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, during mechanical thrombectomy, a 132cm embovac 71 aspiration catheter (ic71132ca, 30541395) was used to remove thrombus at the occlusion located at the m1 segment of the middle cerebral artery (mca).The pass was done with the embovac by a direct aspiration first pass technique.However, the reopening was not obtained.Therefore, the second pass was done with an embotrap ii (product code/lot number unknown) and the embovac.The physician tried to have the embotrap ii (et ii) retracted into the embovac with half remove but there was a resistance felt and the et ii got stuck on the embovac.The physician stopped moving it with force, the et ii and the complaint device were removed from the patient together.The physician observed it outside the patient.The distal end of the embovac looked as it was damaged.It was flushed by saline but leakage from the damaged part was confirmed.After that, the suction catheter was replaced with another device (react71/ medtronic) and it was used together with the et ii to do the third pass.The reopening was obtained.The procedure was completed.
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Manufacturer Narrative
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Product complaint # (b)(4).Updated sections on this medwatch report: b5, d9, e1, e2, e3, g3, g6, h2, h3 and h10.Section b5: additional information received indicated that the event did not result in any consequence or injury to the patient.There is no specification available as to how the distal end was damaged.An adequate flush was maintained through the devices.The devices were used and prepped as per the instructions for use (ifu).Section e1 - initial reporter phone: (b)(6).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) updated section on this medwatch report: b5, b6, g3, g6, h2, h3, h6, h10 and concomitant products.Section b5: additional information was received on 27-sep-2021, continuous suction was implemented with a stryker¿s pump.On the first pass, the physician attempted to perform adapt with the embovac and optimo.The physician didn¿t use the peel-away introducer sheath when attempting to insert the embovac into the rhv attached to the optimo.He struggled to insert the embovac into the rhv.After the embovac was successfully inserted into the optimo through the rhv, he felt some resistance with the delivery of the embovac inside the optimo.The physician did not remember if he unlocked the rhv during retrieval.The manufacturer of rhv is cosmotec (cat number unknown).Adapt was conducted, but the recanalization was not achieved.On the second pass, the physician then used the et ii with the same system (the optimo and the embovac) and phenom 27 microcatheter.After the et ii was successfully deployed at the target location, the physician pulled the et ii proximally to re-sheath half of the et ii body into the embovac.The physician felt resistance right before the proximal part of the et ii was about to enter into the distal lumen of the embovac.The et ii could not be re-sheathed inside the embovac at all.The physician gave up on re-sheathing and removed the et ii, phenom 27 and the embovac together (as a unit) from the patient¿s body.The embovac was visually inspected outside the patient¿s body.Damage at approximately 3 cm from the distal tip and kinks at several locations were noted on the embovac.Saline solution was then flushed through the embovac and leakage was noted at the damaged location.The physician decided to replace the damaged embovac with react 71 for the 3rd pass.On the 3rd pass, the replaced react 71 and the same system were used for the 3rd pass.A slight infarction remained at the periphery; however, tici2b was achieved.The procedure was completed.The sales rep discussed with the physician as a follow up of this complaint event.The assumption from the customer and the sales rep says that the kinks and damage were probably caused by the interaction with the rhv during the insertion or the delivery.The damage then probably caused the resistance which was felt during the delivery of the embovac.Complaint conclusion: as reported by the field, during mechanical thrombectomy, a 132cm embovac 71 aspiration catheter (ic71132ca, 30541395) was used to remove thrombus at the occlusion located at the m1d segment of the middle cerebral artery (mca).The pass was done with the embovac by a direct aspiration first pass technique.However, the reopening was not obtained.Therefore, the second pass was done with an embotrap ii (product code/lot number unknown) and the embovac.The physician tried to have the embotrap ii (et ii) retracted into the embovac with half remove but there was a resistance felt and the et ii got stuck on the embovac.The physician stopped moving it with force, the et ii and the complaint device were removed from the patient together.The physician observed it outside the patient.The distal end of the embovac looked as it was damaged.It was flushed by saline but leakage from the damaged part was confirmed.After that, the suction catheter was replaced with another device (react71/ medtronic) and it was used together with the et ii to do the third pass.The reopening was obtained.The procedure was completed.Additional information received indicated that the event did not result in any consequence or injury to the patient.There is no specification available as to how the distal end was damaged.An adequate flush was maintained through the devices.The devices were used and prepped as per the instructions for use (ifu).Additional information was received on 27-sep-2021, continuous suction was implemented with a stryker¿s pump.On the first pass, the physician attempted to perform adapt with the embovac and optimo.The physician didn¿t use the peel-away introducer sheath when attempting to insert the embovac into the rhv attached to the optimo.He struggled to insert the embovac into the rhv.After the embovac was successfully inserted into the optimo through the rhv, he felt some resistance with the delivery of the embovac inside the optimo.The physician did not remember if he unlocked the rhv during retrieval.The manufacturer of rhv is cosmotec (cat number unknown).Adapt was conducted, but the recanalization was not achieved.On the second pass, the physician then used the et ii with the same system (the optimo and the embovac) and phenom 27 microcatheter.After the et ii was successfully deployed at the target location, the physician pulled the et ii proximally to re-sheath half of the et ii body into the embovac.The physician felt resistance right before the proximal part of the et ii was about to enter into the distal lumen of the embovac.The et ii could not be re-sheathed inside the embovac at all.The physician gave up on re-sheathing and removed the et ii, phenom 27 and the embovac together (as a unit) from the patient¿s body.The embovac was visually inspected outside the patient¿s body.Damage at approximately 3 cm from the distal tip and kinks at several locations were noted on the embovac.Saline solution was then flushed through the embovac and leakage was noted at the damaged location.The physician decided to replace the damaged embovac with react 71 for the 3rd pass.On the 3rd pass, the replaced react 71 and the same system were used for the 3rd pass.A slight infarction remained at the periphery; however, tici2b was achieved.The procedure was completed.The sales rep discussed with the physician as a follow up of this complaint event.The assumption from the customer and the sales rep says that the kinks and damage were probably caused by the interaction with the rhv during the insertion or the delivery.The damage then probably caused the resistance which was felt during the delivery of the embovac.One non-sterile 132cm embovac 71 asp.Catheter was received inside of a pouch.The received device was visually inspected ant it was found that the braided mesh was stretched, no other damages or anomalies were observed during the visual inspection.The device was inspected under a microscope, and it was found that the braided mesh has a hole at the stretch section, no other damages or anomalies were observed during the microscopic test.The id and od from the device was measured and was found within specification.The 132cm embovac 71 asp.Catheter was flushed to verify if any leakage was noted on the device, a leakage was noted at the braided mesh section, the hole noted on the braided mesh during the microscopic analysis is related to the leakage.A manufacturing record evaluation (mre) was performed for the finished device 30541395 number, and no non-conformances related to the malfunction were identified.The product was returned to cerenovus for evaluation.Visual inspection, microscopic inspection, dimensional testing and functional test were conducted on the returned device.The visual analysis of the returned 132cm embovac 71 asp.Catheter revealed that the device has a stretch condition at the braided mesh, no other damages or anomalies were observed during the visual analysis.Based on the results during the visual analysis, the customer complaint regarding ¿distal tip - damaged-in patient¿ was confirmed.During the dimensional testing it was noted that the id and od of the 132cm embovac 71 asp.Catheter is within specification.The 132cm embovac 71 asp.Catheter was inspected under microscope and it was found a hole on the braided mesh at the stretch section, this finding is related with the costumer regarding a ¿catheter (body/shaft) ¿ leakage¿ is related to the stretch condition noted on the device.Based on this information the costumer complaint regarding a leakage was confirmed.The customer complaint regarding a resistance/friction-inner lumen with no loss of cerebral target position could not be duplicate since the device was found stretched at the braided mesh.The stretch condition noted on the device could be related with the resistance/friction reported by the customer, based on this information, the customer complaint regarding a resistance/friction was confirmed.A manufacturing record evaluation (mre) was performed, and no non-conformances related to the reported complaint condition were identified.It should be noted that product failure is multifactorial.Although no conclusion could be reach on the cause of the reported event, the instructions for use contain the following precautions: exercise care in handling the large bore catheter to reduce the chance of accidental damage.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failures and damages on the returned system.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.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).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Section b5: additional information received indicated that the physician did not use a peel-away introducer and that might cause the problem.The physician did not remember if he unlocked the rhv during retrieval.The manufacturer of rhv is cosmotec, cat number not identified.The device was sent to r&d for further investigation, the investigation results are shown below: the proximal end of the unit was found to be slightly ovalized and deformed, it was measured in two planes, and it measured 0.0823¿ in one plane and 0.0839¿ on the other plane.It was confirmed that the unit had the shaft ovalized, it was also noted that the shaft had a clear area where the ovalization began and is consistent with rhv location on base catheter in the fully inserted position.An area of the shaft was measured prior to the ovalization damage and measured 0.0831¿ which is consistent with measurements in production.Based on the description of the complaint below, it seems probable that the catheter could have been damaged during insertion because no introducer was used, also it is possible that the rhv may not have been fully open during insertion and/or retraction of device, the device had issues during insertion, during retraction overtightening of the rhv could cause stretching of the softest polymer on the catheter; the last 7 cm is chronoprene 40a.The base catheter is not suspected of having an issue since a larger device was used to complete the case with a 3rd pass per comments below, react-71 has a max od of 0.0855¿.
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Search Alerts/Recalls
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