MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL HELICAL 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036118300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2016
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.Visual and microscopic evaluation of returned device revealed that the delivery wire was bent, probably due to handling.In addition, the main coil was broken at the detachment zone and at mid section, it was also kinked and stretched, and the suture was damaged.The functional test could not be performed due to the condition of the returned coil.Information available indicated that the customer had confirmed that the target coil was observed to be in good condition prior to use.Furthermore, the coil encountered resistance during advancement and it could not exit the microcatheter; therefore, it was removed and it stretched during removal.It is possible, that the main coil became jammed in the microcatheter during advancement due to some anatomical / procedural factor contributing to the main coil break as well as additional damages observed during analysis.Therefore, based on all available information and device analysis operational context was assigned to the investigation.
Event or Problem Description
Analysis of the returned product revealed that the main coil was broken.There were no clinical consequences to the patient due to this event.

• Brand Name: TARGET XL HELICAL 8MM X 30CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6422362
• Report Number: 3008881809-2017-00082
• Device Sequence Number: 550975
• Product Code: HCG
• UDI-Device Identifier: 07613327004595
• UDI-Public: (01)07613327004595(17)190131(10)18829127
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 03/21/2017

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: 01/31/2019
• Device Catalogue Number: M0036118300
• Device Lot Number: 18829127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2017
• Initial Report FDA Received Date: 03/21/2017
• 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: EXCELSIOR (SL-10)