MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME18 10MM X 34CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR181034
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.Procode: krd/hcg.The device lot number is not available / not reported.The expiration date of the device is not known.The name, phone and email address of the initial reporter are not available / reported.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).The device manufacture date is not known as the product lot number of the device is not available / not reported.[conclusion]: the healthcare professional reported that during the treatment of the aneurysm, the 10mm x 34cm micrusframe 18 coil (mfr181034 / lot#: unknown) and the pusher became separated during placement.There was no report of any procedural delay.The procedure was reported as successfully completed without any delay.There was no report of any patient adverse event or complication as a result of the reported event.Based on complaint information, the device was not available to be returned for analysis.The device lot number was not available.The device history record (dhr) review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.In addition, without a lot number to conduct a device history record review, it is not possible to determine if the reported failure could be related to the manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size / 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 for statistical signals and corrective/preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the treatment of the aneurysm, the 10mm x 34cm micrusframe 18 coil (mfr181034 / lot#: unknown) and the pusher became separated during placement.There was no report of any procedural delay.The procedure was reported as successfully completed without any delay.There was no report of any patient adverse event or complication as a result of the reported event.

• Brand Name: MICRUSFRAME18 10MM X 34CM
• 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: 9546104
• Report Number: 3008114965-2019-01288
• Device Sequence Number: 16750755
• Product Code: KRD
• UDI-Device Identifier: 10886704077213
• UDI-Public: 10886704077213
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2019

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 Catalogue Number: MFR181034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1