MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035466300
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Visual and microscopic analysis of the device revealed that the main coil was physically detached from the returned delivery wire.The main coil itself was not returned.The proximal contact was found to be kinked, the delivery wire was kinked/ bent at multiple locations and was damaged at the distal end.The functional testing was not able to be executed due to the device current conditions, but available information confirmed that the device was in good condition prior to use.It is probable that manipulation during the procedure caused the kinks observed on the proximal contact and the delivery wire.However, the cause for the physical break of the main coil and the observed stretching on the distal delivery wire were not able to be determined.
Event or Problem Description
Analysis of the investigation results revealed that the main coil prematurely detached/separated inside patient.The procedure was successfully completed with no patient consequences.

• Brand Name: TARGET 360 STANDARD 6MM X 30CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6029130
• Report Number: 3008881809-2016-00211
• Device Sequence Number: 19292330
• Product Code: HCG
• UDI-Device Identifier: 07613252239444
• UDI-Public: (01)07613252239444(17)181130(10)18720139
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K112385
• 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): 03/16/2016

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: 11/30/2018
• Device Catalogue Number: M0035466300
• Device Lot Number: 18720139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2016
• Initial Report FDA Received Date: 10/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 ((B)(4))
• Patient Age: 69