MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035424100
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during advancement of the coil through the microcatheter, it detached unexpectedly.The physician removed the microcatheter along with the coil still inside without patient complications.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The coil was returned still inside the microcatheter used during the procedure.Analysis of the returned device revealed that the main coil was heavily stretched, the main coil suture was damaged and the main coil was broken/fractured.The delivery wire was kinked/bent likely due to handling.A functional evaluation could not be performed due to the condition of the device.Information available indicated that the device was confirmed to be in good condition prior to use.Based on analysis of the subject device it is probable that the damage to the delivery wire was due to handling during the procedure.Based on the damages observed to the main coil, it is possible that some friction was experienced during advancement of the coil, and the physician used force in order to remove the coil from the catheter¿s lumen and subsequently the coil stretched contributing to the break.This scenario however cannot be conclusively determined because no resistance was reported.Based on the analysis results and available information, the manufacturer has determined that an unknown procedural factor encountered during procedure contributed to the reported and observed damages to the main coil.Therefore, an assignable cause of operational context was assigned to this investigation.
Event or Problem Description
It was reported that during advancement of the coil through the microcatheter, it detached unexpectedly.The physician removed the microcatheter along with the coil still inside without patient complications.

• Brand Name: TARGET 360 ULTRA 4MM X 10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5752638
• Report Number: 3008881809-2016-00047
• Device Sequence Number: 1122095
• Product Code: HCG
• UDI-Device Identifier: 07613252192336
• UDI-Public: (01)07613252192336(17)190131(10)18784905
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K102672
• 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): 05/30/2016

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: 01/31/2019
• Device Catalogue Number: M0035424100
• Device Lot Number: 18784905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2016
• Supplement Report FDA Received Date: 10/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1