MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK GDC-10 360 6MM X 15CM SR; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M003346615SR0
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual examination of the returned device revealed that dried blood and procedural fluids within the introducer sheath.The introducer sheath was observed to be kinked at 11cm from the distal end likely due to handling damages that limited the performance of the device during procedure.It was also observed that the main coil was physically detached/ separated at the detachment area.The main coil was not returned.During functional testing, the introducer sheath was flushed and traces of blood exited.The delivery wire was advanced through the introducer sheath and resistance was experienced.It is most likely that the friction and observed premature detachment of the main coil were due to some procedural/anatomical factors encountered during use.Therefore, an assignable cause of operational context has been assigned to the friction and observed premature detachment of the main coil.
Event or Problem Description
Based on review of the investigation, it was found that the main coil was prematurely detached inside the patient during insertion into the microcatheter.There was no clinical consequences to the patient.

• Brand Name: GDC-10 360 6MM X 15CM SR
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7616885
• Report Number: 3008881809-2018-00273
• Device Sequence Number: 13801932
• Product Code: HCG
• UDI-Device Identifier: 04546540689672
• UDI-Public: 04546540689672
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 06/19/2018

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: 10/31/2018
• Device Catalogue Number: M003346615SR0
• Device Lot Number: 18615129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 78