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	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the delivery wire was removed from the dispenser hoop, the proximal end of the subject coil was found broken.Another product was used to complete the procedure.No clinical consequences to the patient was reported.
Event or Problem Description
It was reported that when the delivery wire was removed from the dispenser hoop, the proximal end of the subject coil was found broken.Another product was used to complete the procedure.No clinical consequences to the patient was reported.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, it was found that the proximal contact was kinked and broken/fractured and the delivery wire was kinked but not broken.It was also found that the main coil was kinked/bent and stretched likely due to procedural factors that limited the performance of the procedure.The proximal contact was confirmed to be broken which was likely to have been perceived as the delivery wire break.Therefore an assignable cause of handling damage will be assigned to the reported and analyzed coil proximal and coil delivery wire issues.The proximal contact is not a contiguous part that forms the delivery wire but is a subcomponent location at the proximal end of the delivery wire that works in conjunction with the inzone detachment system, and it remains outside the patient at all times during the procedure.It is highly unlikely that the broken proximal contact may contributed to and/or cause any patient injury; the manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• 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: 7540967
• Report Number: 3008881809-2018-00242
• Device Sequence Number: 19441959
• Product Code: HCG
• UDI-Device Identifier: 07613252600305
• UDI-Public: 07613252600305
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K153658
• 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): 08/02/2018

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: 09/30/2020
• Device Catalogue Number: M0035442540
• Device Lot Number: 19983024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 08/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1