MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME14 4MM X 8CM

Catalog Number	MFR140408
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter phone: (b)(6).Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).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 an affiliate, during a coil embolization of gastrointestinal hemorrhage, the physician attempted to confirm the electrical check, but the green system ready light did not illuminate when using the 4mm x 8cm micrusfram14 coil (mfr140408, s13016) and the enpower control cable (ecb00018200, s14553).Therefore, the coil delivery system and the cable were removed, and they were replaced with other products.The procedure continued without any problems and it was completed.Additional information received indicated that a pre-deployment electrical testing was performed.The failure did not occur during pre-deployment electrical check.There was no damage to the devices prior to use.The devices were used and prepped as per the instructions for use (ifu).No further information was provided by hospital.
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 an affiliate, during a coil embolization of gastrointestinal hemorrhage, the physician attempted to confirm the electrical check, but the green system ready light did not illuminate when using the 4mm x 8cm micrusfram14 coil (mfr140408, s13016) and the enpower control cable (ecb00018200, s14553).Therefore, the coil delivery system and the cable were removed, and they were replaced with other products.The procedure continued without any problems and it was completed.Additional information received indicated that a pre-deployment electrical testing was performed.The failure did not occur during pre-deployment electrical check.There was no damage to the devices prior to use.The devices were used and prepped as per the instructions for use (ifu).No further information was provided by hospital.The device was discarded therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device s13016 number, and no non-conformances related to the reported complaint condition were identified.With the information available and without the product available for analysis, the reported customer complaint of ¿coil - failure to detach¿ could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.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 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 with the coil failing to detach.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: MICRUSFRAME14 4MM X 8CM
• Common Device Name: MICRUSFRAME
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 8739704
• Report Number: 3008114965-2019-01069
• Device Sequence Number: 2039888
• Product Code: KRD
• UDI-Device Identifier: 10886704077985
• UDI-Public: 10886704077985
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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: 12/31/2019
• Device Catalogue Number: MFR140408
• Device Lot Number: S13016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 08/08/2019
• 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: DETACHMENT CONTROL BOX; ENPOWER CONTROL CABLE