MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035422030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2016
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 the proximal contact and the delivery wire were kinked likely due to handling damage.The investigation found that the main coil was kinked/bent, tangled and stretched likely to procedural factors.Additionally, the delivery wire was found to be broken.Following identification of the delivery wire break and further inspection under a microscope, evidence of arcing was noted at the site of the delivery wire break that was confirmed per scanning electron microscopy (sem) analysis.The damage noted to the delivery wire during analysis is indicative of electrolytic degradation caused by the use of a grounding cable.As per dfu "do not use detachment systems other than the inzone detachment system".Therefore, an assignable cause of user error has been assigned to observed delivery wire break.
Event or Problem Description
Based on the investigation of the returned product, it was found that the coil delivery wire was broken/fractured.There was no impact to the patient.

• Brand Name: TARGET 360 ULTRA 2MM X 3CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6444212
• Report Number: 3008881809-2017-00094
• Device Sequence Number: 501060
• Product Code: HCG
• UDI-Device Identifier: 04546540675835
• UDI-Public: (01)04546540675835(17)180930(10)18591688
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2017

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 Catalogue Number: M0035422030
• Device Lot Number: 18591688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2017
• Initial Report FDA Received Date: 03/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1