MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2.5 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035442540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available.
Event or Problem Description
It was reported that resistance was encountered as the coil was advanced into the microcatheter ans the coil broke during placement into the microcatheter.No further details were provided.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual and microscopic inspection of the returned device found that the delivery wire and the proximal contact were kinked.The observed issues were likely caused by the handling of the device.The main coil was kinked and there was no evidence of fracturing or breaking.The device was advanced out of the introducer sheath with resistance.It is most probable that procedural factors encountered during the procedure limiting the performance of the device and contributed to the observed main coil kinked and coil introducer sheath friction.All dimension were within specification.Investigation of the returned device did not find any evidence of the coil breakage.Therefore, the reported issue of the coil broke was not confirmed.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that resistance was encountered as the coil was advanced into the microcatheter ans the coil broke during placement into the microcatheter.No further details were provided.

• Brand Name: TARGET 360 NANO 2.5 MM X 4 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5847886
• Report Number: 3008881809-2016-00111
• Device Sequence Number: 417376
• Product Code: HCG
• UDI-Device Identifier: 07613252600305
• UDI-Public: (01)07613252600305(17)190630(10)19108564
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K113412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2016

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: 06/30/2019
• Device Catalogue Number: M0035442540
• Device Lot Number: 19108564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2016
• Supplement Report FDA Received Date: 11/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1