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 Patient Involvement (2645)
Date of Event	05/28/2018
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 examination of the returned device revealed that the main coil was stretched and broken on the coil wind and the main coils suture was damaged.During functional testing, the coil was attempted to be advanced through the introducer sheath but there was resistance noted.When retracting the device through the introducer sheath, the coil can be seen to be detached from the delivery wire.Based on the information available, it was stated that the prematurely detachment was noticed out of the patient prior to the procedure.Therefore, an assignable cause of handling damage has been assigned to this investigation.
Event or Problem Description
After reviewing the investigation, it was revealed that the main coil was broken.There were no clinical consequences 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: 7891915
• Report Number: 3008881809-2018-00407
• Device Sequence Number: 1837192
• Product Code: HCG
• UDI-Device Identifier: 07613252600329
• UDI-Public: 07613252600329
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 09/19/2018

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: No Information
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: M0035443060
• Device Lot Number: 19608267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1