MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 14MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036101450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the embolization procedure the subject device encountered a lot of resistance when was advanced through the microcatheter.After placement into the aneurysm the device was unable to be detached and physician has decided to retract the coil.During the retrieval the main coil broke, having a thin filament attached to the coil that made safe and complete removal of the broken device from the patient possible.There was no clinical consequence reported due to this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Visual inspection of the returned device revealed that the proximal contact was not attached, likely due to handling.The proximal contact was not returned.Device visual and microscopic evaluation revealed that the delivery wire was damaged and broken; the break site upon inspection revealed an evidence of arcing, which is an indication of an incorrect detachment technique used during the procedure and indicative of use error.In addition, procedural fluid was found around the detachment zone which could contribute to detachment and friction issues during the procedure.No anomalies to the main coil were noted.Functional testing could not be performed due to condition of the returned device.Information available indicated that the delivery wire was damaged during coil withdrawal due to some resistance, which most likely was perceived by the user as the main coil breakage; however, no break was observed to the main coil.Based on device analysis and available information an assignable cause of operational context was assigned to the reported event.
Event or Problem Description
It was reported that during the embolization procedure, the subject device encountered a lot of resistance when was advanced through the microcatheter.After placement into the aneurysm, the device was unable to be detached and physician has decided to retract the coil.During the retrieval the main coil broke, ¿leaving a thin filament attached to the coil¿ that made safe and complete removal of the broken device from the patient possible.There was no clinical consequence reported due to this event.

• Brand Name: TARGET XL 360 STANDARD 14MM X 50CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5854843
• Report Number: 3008881809-2016-00117
• Device Sequence Number: 1242468
• Product Code: HCG
• UDI-Device Identifier: 04546540711298
• UDI-Public: (01)04546540711298(17)181031(10)18647695
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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,Followup
• Report Date (Section B): 04/17/2017

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: 10/31/2018
• Device Catalogue Number: M0036101450
• Device Lot Number: 18647695
• 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: 07/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2016
• Supplement Report FDA Received Date: 04/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 120