MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL G2 HELICAL XTRASOFT COIL 2X8; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	641HX0208
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization to the right anterior communicating artery (acon), a 2x8 orbit galaxy enpower xtrasoft coil (641hx0208, s10340) was not able to place through the prowler lpes 14, straight microcatheter (mc) smoothly and was required more push.Hence, the doctor decided to withdraw the coil without the need to additional intervention and replace it with another galaxy coil to complete the case.There was no surgery delayed due to the reported event.The procedure was successfully completed.There was no patient injury.Additional information received indicated that other devices were successfully used with the microcatheter prior to or after the encountered resistance.The event did not result in a loss of cerebral target position.The microcatheter was not damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.The actual coil did not appear damaged at any time.Nothing was noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during coil advancement.No excessive force was applied to the device.Based on the product analysis of the device received, the embolic coil has a stretched condition, and the embolic coil was found entangled with the device.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.Based on the product analysis of the device received, the embolic coil has a stretched condition, and the embolic coil was found entangled with the device.The findings meet regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.(b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Complaint conclusion: as reported by the field, during a coil embolization to the right anterior communicating artery (acon), a 2x8 orbit galaxy enpower xtrasoft coil (641hx0208, s10340) was not able to place through the prowler lpes 14, straight microcatheter (mc) smoothly and was required more push.Hence, the doctor decided to withdraw the coil without the need to additional intervention and replace it with another galaxy coil to complete the case.There was no surgery delayed due to the reported event.The procedure was successfully completed.There was no patient injury.Additional information received indicated that other devices were successfully used with the microcatheter prior to or after the encountered resistance.The event did not result in a loss of cerebral target position.The microcatheter was not damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.The actual coil did not appear damaged at any time.Nothing was noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during coil advancement.No excessive force was applied to the device.A non-sterile unit g2 helical xtrasoft coil 2x8 was received inside of a pouch.The device was visually inspected, and it was found that the dpu is broken in two, the introducer and the hub were not returned for evaluation with the rest of the device, no other damages or anomalies were observed during the visual inspection.A microscopic inspection was performed, and it was found that the embolic coil has a stretched condition, the embolic coil was found entangled with the device.The functional test could not be performed due to the condition in which the device was returned.Due to the broken condition noted on the dpu a scanning electron microscope (sem) testing was performed, the results of the scanning electron microscope (sem) test are as follows.There is evidence of mechanical damage and stress marks on dpu.These damages could be related to the handling of the device during the procedure or excessive force; however, this cannot be conclusively determined.No other anomalies were observed.A manufacturing record evaluation (mre) was performed for the finished device s10340 number, and no non-conformances related to the reported complaint condition were identified cerenovus conducted a visual and microscopic inspection.The functional test could not be performed due to the condition in which the device was returned for analysis.During the visual analysis of the device, it was noted that the dpu is broken in two, the hub and the introducer were not returned for evaluation.The broken condition noted on the dpu could be the result of the resistance/friction condition reported by the customer, however, this cannot be conclusively determined.Procedural and other factors may contribute to the findings; however, this cannot be conclusively determined.Based on the findings during the analysis, the customer complaint regarding a resistance/friction-during advancement was confirmed.The device was inspected under a microscope, and it was found that the embolic coil is stretched and entangled with the dpu.Procedural and other factors may contribute to the finding; however, this cannot conclusively determined.Based on the findings during the analysis, the customer complaint was confirmed.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.Resistance/friction during advancement is a known potential product failure associated with the use of the device.It should be noted that product failure is multifactorial.The instructions for use do contain the following recommendations: ¿ if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.¿ if the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the microcatheter at or slightly inside the ostium (neck) of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.¿ pulling the exposed microcoil through the rhv grommet may damage the coil.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 failure and damages on the returned system.An embolic coil becomes stretched when an excessive pull force is applied to the device, it is possible that it might have been caused by the resistance noted in the event description.As part of 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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: G2 HELICAL XTRASOFT COIL 2X8
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 12656326
• Report Number: 3008114965-2021-00524
• Device Sequence Number: 1309935
• Product Code: KRD
• UDI-Device Identifier: 10878528009419
• UDI-Public: 10878528009419
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K120686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 641HX0208
• Device Catalogue Number: 641HX0208
• Device Lot Number: S10340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROWLER LPES 14