MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035432080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly, and performance specifications.Visual inspection of the device revealed that it the delivery was kinked and was also noted to be broken at approximately 74 cm from the proximal end.It is probable that the delivery wire became kinked and subsequently broke as a result of the handling of the device during the clinical procedure.Therefore, an assignable cause of handling damage has been assigned to the observed break.
Event or Problem Description
Analysis of the returned device revealed that the coil delivery wire was broken.There were no clinical consequences to the patient reported as a result of the event.

• Brand Name: TARGET HELICAL ULTRA 2MM 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: 5900885
• Report Number: 3008881809-2016-00137
• Device Sequence Number: 18837724
• Product Code: HCG
• UDI-Device Identifier: 04546540676023
• UDI-Public: 0104546540676023171808311018569480
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K112385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2016

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: 08/31/2018
• Device Catalogue Number: M0035432080
• Device Lot Number: 18569480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2016
• Initial Report FDA Received Date: 08/24/2016
• 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: EXCELSIOR XT-27 (STRYKER)