MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 7MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035477200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2018
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 the coil delivery wire was kinked as the result of handling of the device during the preparation of the device, or during clinical procedure.Additionally, the main coil was found to be detached from the delivery wire and the distal delivery wire coil was noted to be broken.Functional testing could not be performed due to the condition of the returned device.In the case of this complaint it was reported that the target coil failed to detach during the clinical procedure.The returned device was inspected and the distal delivery wire coil was found broken/fractured, and the delivery wire was kinked/bent.These defects could have led to the reported detachment failure if occurred before attempted detachment.This however cannot be proven.It is possible that the damage to the device and the reported event occurred due to inappropriate handling of the device after unsuccessful detachment.Based on the information provided and investigation results, the main coil failed to detach during the procedure most likely due to some procedural/anatomical factors encountered during use.Therefore, an assignable cause of procedural factors - cause traced to component failure was assigned to the reported coil failed to detach and analyzed coil break.
Event or Problem Description
Analysis of the device revealed that the coil was broken.There were no clinical consequences reported to the patient.

• Brand Name: TARGET 360 SOFT 7MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8237477
• Report Number: 3008881809-2019-00016
• Device Sequence Number: 11234523
• Product Code: HCG
• UDI-Device Identifier: 04546540676573
• UDI-Public: 04546540676573
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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
• Report Date (Section B): 01/10/2019

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: 06/23/2021
• Device Catalogue Number: M0035477200
• Device Lot Number: 20484016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1