MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK GDC-18 360 7MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0033487150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.Visual inspection of the device revealed the delivery wire was noted to be broken/ fractured and the main coil was stretched.A functional test was unable to be performed due to the condition of the returned device.As per the additional information, the coil was inspected and confirmed to be in good condition during/after unpacking and preparation and the device was prepared as per the dfu.Based on received information, slight force was applied to advance the coil.The analyzed defects are indicative of the reported event.It is probable that the device was damaged due to the reported coil in catheter friction.Based on the investigation results and available information, an assignable cause of procedural factors was assigned to this investigation.
Event or Problem Description
Based on the investigation of the returned product, the delivery wire was found to be broken inside the patient.There we no clinical consequences to the patient.

• Brand Name: GDC-18 360 7MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8480716
• Report Number: 3008881809-2019-00089
• Device Sequence Number: 13766570
• Product Code: HCG
• UDI-Device Identifier: 04546540690005
• UDI-Public: 04546540690005
• 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): 04/03/2019

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: 02/29/2020
• Device Catalogue Number: M0033487150
• Device Lot Number: 19667510
• 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: 03/25/2019
• Initial Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 54