MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035422040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during the procedure, the coil was unable to be advanced into the microcatheter as it appeared to be broken.No impact to the patient was reported.No further information is available.
Additional Manufacturer Narrative
A review of the manufacturing history record could not be performed because the lot number was not available.Analysis of the device revealed that the main coil and was stretched.During function evaluation the coil was able to be advanced through the introducer sheath without difficulties; however, resistance was experienced as the coil was being advanced into the hub of the demonstration microcatheter, likely due to main coil stretched.The reported main coil break was not observed; however, it is probable that the user may have perceived the main coil stretched as being broken.The manufacturer has reviewed all information and determined this event no longer meets the requirements of the reportable event for the device in question.
Event or Problem Description
It was reported that during the procedure, the coil was unable to be advanced into the microcatheter as it appeared to be broken.The coil was removed out of the catheter with ease.The procedure was completed with the new coil.No impact to the patient was reported.No further information is available.

• Brand Name: TARGET 360 ULTRA 2MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork CA NA
• MDR Report Key: 5840944
• Report Number: 3008881809-2016-00103
• Device Sequence Number: 1172470
• Product Code: HCG
• UDI-Device Identifier: 04546540675842
• UDI-Public: (01)04546540675842(17)190331(10)18933545
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K102672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2017

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 Catalogue Number: M0035422040
• Device Lot Number: 18933545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2016
• Supplement Report FDA Received Date: 03/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1