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

Catalog Number	M0036129300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2016
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 without the introducer sheath.Visual inspection of the device revealed that the main coil was heavily stretched and broken.The main coil suture was damaged.In addition the delivery wire was found kinked likely due to handling.Functional testing could not be performed due to the condition of the returned device.Information available indicated that the main and delivery wire were confirmed to be in good condition prior to use.It is likely that the break as well as damages observed to the main coil were due to some procedural/anatomical factor limiting its performance.Based on the investigation results and available 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 was broken/ fractured.No consequences to the patient were reported.

• 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: 6446442
• Report Number: 3008881809-2017-00096
• Device Sequence Number: 425041
• Product Code: HCG
• UDI-Device Identifier: 04546540711618
• UDI-Public: (01)04546540711618(17)190331(10)18954484
• 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): 03/30/2017

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: 03/31/2019
• Device Catalogue Number: M0036129300
• Device Lot Number: 18954484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2017
• Initial Report FDA Received Date: 03/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1