MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3.5MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423580
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
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Analysis of the device revealed that the delivery wire was broken/fractured.In addition the delivery wire proximal contact was detached and the delivery wire kinked/bent likely due to handling.During functional evaluation resistance was encountered when the coil was advanced through the introducer sheath.Information available indicated that the target device was confirmed to be in good condition prior to use.Based on the information currently available, the delivery wire damages as well as the observed break are due to handling during use limiting the target performance.An assignable cause of handling damage was assigned to this investigation.
Event or Problem Description
Device analysis of the returned device, revealed that the coil delivery wire was broken/fractured.There was no impact to the patient.

• Brand Name: TARGET 360 ULTRA 3.5MM X 8CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6520810
• Report Number: 3008881809-2017-00127
• Device Sequence Number: 1201960
• Product Code: HCG
• UDI-Device Identifier: 04546540714756
• UDI-Public: (01)04546540714756(17)190731(10)19169798
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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
• Report Date (Section B): 04/25/2017

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: M0035423580
• Device Lot Number: 19169798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/25/2017
• 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: MICROCATHETER (UNKNOWN)