MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK GDC-10 360 SOFT 3MM X 6CM SR; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M003347306SR0
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2017
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 inspection of the device revealed that the main coil had prematurely detached from the coil delivery wire.The main coil was noted to be kinked and stretched as well.Functional testing could not be performed due to the damaged condition of the returned coil.Based on the information currently available,it is likely that the main coil was damaged during use thus limiting the performance of the coil during the clinical procedure.Therefore, an assignable cause of operational context has been assigned to this investigation.
Event or Problem Description
Analysis of the returned device noted that the main coil had prematurely detached from the coil delivery wire.No consequences to the patient were reported.

• Brand Name: GDC-10 360 SOFT 3MM X 6CM SR
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7383949
• Report Number: 3008881809-2018-00141
• Device Sequence Number: 172842
• Product Code: HCG
• UDI-Device Identifier: 04546540689801
• UDI-Public: (01)04546540689801(17)180930(10)18613621
• 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): 03/29/2018

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: 09/30/2018
• Device Model Number: M003347306SR0
• Device Catalogue Number: M003347306SR0
• Device Lot Number: 18613621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR