MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 8MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035478200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a coil embolization procedure, the subject coil fractured in the (non-stryker) microcatheter.The coil and the microcatheter were removed altogether as one unit.There was no impact to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The coil was returned within an echelon 10 microcatheter.Visual and microscopic examination of the returned device revealed that the main coil was stretched and extending out from the hub of the microcatheter.During functional testing, the microcatheter was flushed and blood exited the microcatheter.A 0.0158¿ patency mandrel was advanced through the microcatheter from the distal end in an attempt to remove the coil; however the coil could not be removed from the microcatheter.The main coil stretch and jamming issue were most likely due to procedural factors.It was also observed that the coil delivery wire was kinked likely due to handling damages that limited the performance of the procedure.The reported main coil break was not confirmed, however it is probable that the stretched coil was perceived as being broken.Therefore, an assignable cause of "unable to confirm the complaint" has been assigned to the reported main coil break.
Event or Problem Description
It was reported that during a coil embolization procedure, the subject coil fractured in the (non-stryker) microcatheter.The coil and the microcatheter were removed altogether as one unit.There was no impact to the patient.

• Brand Name: TARGET 360 SOFT 8MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6147450
• Report Number: 3008881809-2016-00289
• Device Sequence Number: 19051607
• Product Code: HCG
• UDI-Device Identifier: 04546540676597
• UDI-Public: (01)04546540676597(17)190731(10)19206144
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093142
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2017

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: 07/31/2019
• Device Catalogue Number: M0035478200
• Device Lot Number: 19206144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 04/20/2017
• 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: ECHELON-10 MICROCATHETER (COVIDIEN)