MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS INC, CODMAN & SHURTLEFF, INC. MICRUSFRAME S STRETCH RESISTENT COIL; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	MFR181240
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
While attempting to explant a coil, the coil stretched and broke.A portion of the implant remained in the patient for a short period of time, but was able to be fully retrieved.Fda safety report id# (b)(4).

• Brand Name: MICRUSFRAME S STRETCH RESISTENT COIL
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS INC, CODMAN & SHURTLEFF, INC. ; le locle, ch
• MDR Report Key: 10413100
• Report Number: MW5096081
• Device Sequence Number: 12970777
• Product Code: HCG
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 08/12/2020

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: 04/30/2020
• Device Catalogue Number: MFR181240
• Device Lot Number: L15838
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 109