MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035443060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned with the introducer sheath and dispenser hoop.Device analysis revealed that the main coil was stretched and broken, and the delivery wire was kinked likely due to handling.During functional evaluation of the coil, friction was observed when the coil was pushed through the introducer sheath.The device was confirmed to be in good condition prior to use.It is likely that friction was encountered due to some procedural factors encountered during the procedure and that the coil stretched and broke when excessive force was applied while pulling the coil out from the introducer sheath.Based on information available and device analysis an assignable cause of operational context has been assigned to this investigation.
Event or Problem Description
Analysis of the returned device revealed that the main coil was broken/fractured.There was no impact to the patient.

• Brand Name: TARGET 360 NANO 3 MM X 6 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6583698
• Report Number: 3008881809-2017-00155
• Device Sequence Number: 616437
• Product Code: HCG
• UDI-Device Identifier: 07613252600329
• UDI-Public: (01)07613252600329(17)191031(10)19384343
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K113412
• 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): 05/22/2017

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: 10/31/2019
• Device Catalogue Number: M0035443060
• Device Lot Number: 19384343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2017
• Initial Report FDA Received Date: 05/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1