MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 9MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036129300
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned.Analysis of the device revealed that coil delivery wire was kinked, main coil was stretched and kinked, and the main coil was prematurely detached inside patient.Functional testing could not be performed due to the condition of the returned device.It was reported that the anatomy was noted to be mildly tortuous and the main coil was noted to be repositioned more than once.Based on the review and analysis of available information it is likely that damage was sustained to the main coil during placement causing the anomalies on the main coil.In addition, the anomalies on the delivery wire is due to handling of the device or portion of the device during the clinical procedure, upon removal of the device from the packaging, or preparation of the device prior to use.
Event or Problem Description
During the analysis of the returned device, it was found that the main coil prematurely detached inside patient.No clinical consequences reported to the patient.

• Brand Name: TARGET XL 360 SOFT 9MM 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: 6482362
• Report Number: 3008881809-2017-00103
• Device Sequence Number: 850180
• Product Code: HCG
• UDI-Device Identifier: 04546540711618
• UDI-Public: (01)04546540711618(17)190831(10)19215769
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123377
• 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): 04/11/2017

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: 08/31/2019
• Device Catalogue Number: M0036129300
• Device Lot Number: 19215769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2017
• Initial Report FDA Received Date: 04/11/2017
• 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: SL-10 MICROCATHETER (STRYKER)