MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME10 8MM X 29CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR100829
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.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.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.
Event or Problem Description
As reported by the field, during an embolization of intracranial aneurysm, an 8mm x 29cm micrusframe10 coil (mfr100829, l11201) did not detached from the guide, after multiple attempts.Having made attempts in which the cable and battery were changed.To manage the problem during the procedure, the physician removed the coil from the aneurysm sac.There was no report of patient injury.Additional information received indicated that pre-deployment electrical testing was performed, the reported failure did not occur during testing.The catalog and lot number for the connecting cable used with the coil is unknown.The connecting cable is not available for analysis.The same dcb was used successfully with subsequent coils.The second connecting cable was used successfully with subsequent coils.When the micrusframe10 coil was removed from the patient, the actual coil was still attached to the coil delivery system.The procedure was completed by using another coil.The event prolonged the procedure by a few minutes, it was not significant.There was no calcification at the targeted vessel, there was normal tortuosity and the diameter of the vessel was 4.5mm.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported by the field, during an embolization of intracranial aneurysm, an 8mm x 29cm micrusframe10 coil (mfr100829, l11201) did not detach from the guide, after multiple attempts.Having made attempts in which the cable and battery were changed.To manage the problem during the procedure, the physician removed the coil from the aneurysm sac.There was no report of patient injury.Additional information received indicated that pre-deployment electrical testing was performed, the reported failure did not occur during testing.The catalog and lot number for the connecting cable used with the coil is unknown.The connecting cable is not available for analysis.The same dcb was used successfully with subsequent coils.The second connecting cable was used successfully with subsequent coils.When the micrusframe10 coil was removed from the patient, the actual coil was still attached to the coil delivery system.The procedure was completed by using another coil.The event prolonged the procedure by a few minutes, it was not significant.There was no calcification at the targeted vessel, there was normal tortuosity and the diameter of the vessel was 4.5mm.A non-sterile unit micrusframe10 8mm x 29cm was received inside of a pouch.The device was inspected, and it was found with a kinked condition at core wire, no other damages or anomalies were observed during the visual analysis.Also, the marker band was found at 64 cm from hub, and it was found within specification.The embolic coil was inspected under a microscope and it was found in good normal conditions.The resistance of the device galaxy g3 mini 3mm x 4cm was measured with a multimeter.Resistance initially measured approximately 55.6 o, which is in of the specification range.Also, the device was connected to detachment control box dcb2000500 (dcb) with an enpower control cable lab sample and the power was turned on.The system ready light was illuminating.The detach button was pressed.And the embolic coil was detached.A manufacturing record evaluation was performed for the finished device l11201 number, and no non-conformances related to the reported complaint condition were identified the complaint reported by the customer ¿coil - failure to detach¿ was not confirmed, during the functional test, the system ready light was illuminating.The detach button was pressed and the embolic coil was detached.The kinked condition noted on the device may have been related with the handling of the device, however the exact time when this condition appeared is unknown, however, this finding is not related with the customer¿s complaint.Neither the analysis nor the mre suggests that the failure reported by the customer could be related to the manufacturing process.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.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.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 8MM X 29CM
• 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: 10843203
• Report Number: 3008114965-2020-00521
• Device Sequence Number: 17076837
• Product Code: KRD
• UDI-Device Identifier: 10886704077909
• UDI-Public: 10886704077909
• Combination Product (Y/N): N
• PMA/510(K) Number: K150319
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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: 12/31/2020
• Device Model Number: MFR100829
• Device Catalogue Number: MFR100829
• Device Lot Number: L11201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 12/17/2020
• 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: UNK CONNECTING CABLE; UNK DETACHMENT CONTROL BOX; UNK CONNECTING CABLE.; UNK DETACHMENT CONTROL BOX.
• Patient Age: 45 YR