MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME10 6MM X 26CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR100626
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).The purpose of this mdr is to include the additional event information received on 7/11/2019.The additional event information resulted in a change in the reportability of this complaint.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter phone/fax: (b)(6).Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.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.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization to the left middle cerebral artery (mca), a 6mm x 26cm micrusframe10 coil (mfr100626, l13454) did not ¿slip¿ on the echelon 10.Microcatheter (mc).The event occurred 10 or 15cm after the hub.It was not possible to position it on the aneurysm.The user took out the coil and the microcatheter to check if the issue came from the coil or the mc, but no kink on the mc.There was no patient injury reported.Another micrusframe10 coil from another lot was used perfectly with the same mc.There was no clinically significant procedural delay due to the event.Additional information received indicated that the coil did not exit the catheter.Adequate and continuous flush was maintained through the catheter.There was no difficulty during introduction of the catheter over the guide wire prior to the attempted use of the device.The microcatheter had no kinked or bent at any time prior to the resistance/friction.The coil was still attached to the device and there was no actual damage noted on the device when removed from the patient.The vessel was not excessively tortuous or with acute bends.
Additional Manufacturer Narrative
Product complaint#: (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by a healthcare professional, during a coil embolization to the left middle cerebral artery (mca), a 6mm x 26cm micrusframe10 coil (mfr100626, l13454) did not ¿slip¿ on the echelon 10.Microcatheter (mc).The event occurred 10 or 15cm after the hub.It was not possible to position it on the aneurysm.The user took out the coil and the microcatheter to check if the issue came from the coil or the mc, but no kink on the mc.There was no patient injury reported.Another micrusframe10 coil from another lot was used perfectly with the same mc.There was no clinically significant procedural delay due to the event.Additional information received indicated that the coil did not exit the catheter.Adequate and continuous flush was maintained through the catheter.There was no difficulty during introduction of the catheter over the guide wire prior to the attempted use of the device.The microcatheter had no kinked or bent at any time prior to the resistance/friction.The coil was still attached to the device and there was no actual damage noted on the device when removed from the patient.The vessel was not excessively tortuous or with acute bends.One non-sterile micrusframe10 6mm x 26cm was received inside of a pouch.The hub was inspected, and it was found with no damages on it.The dpu was inspected and it was found in good conditions.The introducer was received separated from the unit.It was inspected and no damages was noted on it.The re-sheating tool was inspected and it was found with no damages on it.Also, the marker band was found at 61cm from distal end and it was found within specification.The v-notch was inspected under microscope and it was found in good conditions.The rh was inspected under microscope and it was found with no damages on it outside from the introducer.The embolic coil was found outside the introducer, no damages was noted on it.A manufacturing record evaluation was performed for the finished device l13454 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿detachable coil delivery system (dcs)- impeded in microcatheter with loss of cerebral target position¿ was not able to be confirmed since due the conditions of the received device (introducer separated from unit) was not able to be evaluated.Neither the device history record review nor the product analysis suggest that the reported failure could be related to the manufacturing process of the unit.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint devices; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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: MICRUSFRAME10 6MM X 26CM
• 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: 8851220
• Report Number: 3008114965-2019-01107
• Device Sequence Number: 18903508
• Product Code: KRD
• UDI-Device Identifier: 10886704077862
• UDI-Public: 10886704077862
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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: 07/31/2021
• Device Catalogue Number: MFR100626
• Device Lot Number: L13454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 08/15/2019
• 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: ECHELON 10.
• Patient Age: 65 YR
• Patient Weight: 60