MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK GDC-18 360 14MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M00334814300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the main coil was stretched and broken.Functional testing could not be performed due to the condition of the device.The reported issue is covered in the device directions for use.The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.It is most likely that the coil stretched and then broke during manipulation of the coil against friction.Therefore, a cause of procedural factors will be assigned to the investigation.
Event or Problem Description
Analysis of the returned device found that the main coil had broken inside the patient.There was no clinical consequence to the patient as a result of this event.

• Brand Name: GDC-18 360 14MM 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: 9101447
• Report Number: 3008881809-2019-00288
• Device Sequence Number: 16924826
• Product Code: HCG
• UDI-Device Identifier: 04546540689917
• UDI-Public: 04546540689917
• 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): 09/21/2019

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: 10/31/2019
• Device Catalogue Number: M00334814300
• Device Lot Number: 19438818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 09/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR