MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2.5 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035442540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reporting that during coil embolization, resistance was experienced within the microcatheter distal tip.Medical intervention using a snare device was necessary to retrieve the coil.There was no patient impact.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.Information available indicated that the device was confirmed to be in good condition prior to use but the event description indicated that "doctor thought that preparing of coil by assistant was wrong." however this cannot be conclusively determined.Therefore a cause of undeterminable will be assigned to this complaint.The manufacturer has reviewed all information and determined that there was no medical intervention to retrieve the subject coil jammed in the tip of the catheter.The manufacturer has determined that this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reporting that during coil embolization, the subject coil was jammed at the microcatheter distal tip.The physician collected the coil and finished the procedure.There was no patient impact.

• Brand Name: TARGET 360 NANO 2.5 MM X 4 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5772197
• Report Number: 3008881809-2016-00067
• Device Sequence Number: 315863
• Product Code: HCG
• UDI-Device Identifier: 07613252600305
• UDI-Public: (01)07613252600305(17)190131(10)18831210
• Combination Product (Y/N): N
• PMA/510(K) Number: K113412
• 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): 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: M0035442540
• Device Lot Number: 18831210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2016
• Supplement Report FDA Received Date: 09/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention