MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK GDC-18 360 12MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M00334812300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.Visual & microscope inspections revealed that the delivery wire was noted to be kinked 50 & 57cm from the proximal end.The main coil was extensively stretched and it was also broken from the delivery wire at the main junction.Functional testing could not be performed due to the damaged condition of the returned device.The device was confirmed to be in good condition prior to use and the device was prepared as per the dfu.Information available indicated that resistance was observed of coil within the microcatheter.Based on the information currently available, it is probable that some procedural factors encountered during the procedure limited the performance of the coil contributing to the reported and observed damages.Therefore, an assignable cause of component failure has been assigned to this investigation.
Event or Problem Description
Analysis of the returned device noted that the coil was broken.No consequences to the patient were reported.

• Brand Name: GDC-18 360 12MM X 30CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8484049
• Report Number: 3008881809-2019-00090
• Device Sequence Number: 1576535
• Product Code: HCG
• UDI-Device Identifier: 04546540689894
• UDI-Public: 04546540689894
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K042539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2019

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: 11/30/2019
• Device Catalogue Number: M00334812300
• Device Lot Number: 19479666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/04/2019
• 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: EXCELSIOR MICROCATHETER(STRYKER)
• Patient Age: 49 YR