MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035422540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the coil encountered resistance during insertion into microcatheter and broke.There was no clinical consequence to the patient as a result of this event.
Additional Manufacturer Narrative
Based on the results of the device history review (dhr) review, there is no indication that the device, labelling or packaging failed to meet its specifications when released.Inspection of the returned device found the main coil was damaged (stretched and suture damage), the delivery wire was kinked and friction was felt when the coil was advanced through the sheath during functional testing; no other anomalies were found.No break/fracture was observed during inspection of the main coil as previously reported.Based on results of the investigation and available information, the reported coil broken/fractured was not confirmed.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported the coil encountered resistance during insertion into microcatheter and broke.There was no clinical consequence to the patient as a result of this event.

• Brand Name: TARGET 360 ULTRA 2.5MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7519072
• Report Number: 3008881809-2018-00228
• Device Sequence Number: 1528783
• Product Code: HCG
• UDI-Device Identifier: 07613327313918
• UDI-Public: (01)07613327313918(17)201031(10)20087152
• Combination Product (Y/N): N
• 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): 07/16/2018

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: 10/31/2020
• Device Catalogue Number: M0035422540
• Device Lot Number: 20087152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1