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

Model Number	MFR100626
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2020
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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization of an aneurysm at the left ophthalmic, an empower control cable (catalog/lot number unknown) couldn't seat properly with the enpower dcb 2 output connector; the dcb output connector appeared damage.The cable was ultimately able to connect to the dcb connector, but it's unclear if the user felt the actual click on attempt to connect.The cable was replaced but the issue continued.The 6mm x 26cm micrusframe10 coil (mfr100626, 30370540) was subsequently removed from the patient and both the dcb and coil were replaced to complete the procedure.The coil was not re-challenged.There was no patient injury reported.The device(s) were used and prepped as per the instructions for use (ifu).
Additional Manufacturer Narrative
Product complaint #(b)(4).Updated sections on this medwatch report: d10, g4, g7, h2, h3, h6 and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.As reported by a healthcare professional, during a coil embolization of an aneurysm at the left ophthalmic, an enpower control cable (catalog/lot number unknown) couldn't seat properly with the enpower dcb 2 output connector; the dcb output connector appeared damage.The cable was ultimately able to connect to the dcb connector, but it's unclear if the user felt the actual click on an attempt to connect.The cable was replaced but the issue continued.The 6mm x 26cm micrusframe10 coil (mfr100626, 30370540) was subsequently removed from the patient and both the dcb and coil were replaced to complete the procedure.The coil was not re-challenged.There was no patient injury reported.The device(s) were used and prepped as per the instructions for use (ifu).A non-sterile unit micrusframe10 6mm x 26cm was received inside of a pouch.The device was visually inspected, and it was found in good normal conditions, no anomalies or damages were observed during the visual inspection.The device was inspected under a microscope and it was found in good normal conditions.The resistance of the device micrusframe10 6mm x 26cm was measured with multimeter.Resistance initially measured approximately 53.1 o, which is within of the specification range.Also, the device was connected to the received detachment control box 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 detached.A manufacturing record evaluation was performed for the finished device 30370540 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 detached.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 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: 10573892
• Report Number: 3008114965-2020-00430
• Device Sequence Number: 1282687
• Product Code: KRD
• UDI-Device Identifier: 10886704077862
• UDI-Public: 10886704077862
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

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: 01/31/2023
• Device Model Number: MFR100626
• Device Catalogue Number: MFR100626
• Device Lot Number: 30370540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 10/19/2020
• 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: ENPOWER DCB 2.; UNK CONNECTING CABLE.; ENPOWER DCB 2; UNK CONNECTING CABLE