MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423100
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the coil stretched and detached prematurely.The coil was retrieved.There was no clinical consequence to the patient.No further details provided.
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.Visual inspection revealed that the main coil was broken, stretched out and tangled.No other anomalies were observed.Functional testing could not be performed due to the damage on the device.The device was confirmed to be in good condition prior to use.It is possible that some friction was experienced during advancement and the physician used excessive force in order to remove the coil from the catheter¿s lumen and subsequently the coil became stretched, tangled and detached inside the microcatheter.However the exact cause that contributed to this friction which resulted in the broken and prematurely detachment of the main coil could not be definitively determined.
Event or Problem Description
It was reported that during procedure the coil stretched and detached prematurely.The coil was retrieved.There was no clinical consequence to the patient.No further details provided.

• Brand Name: TARGET 360 ULTRA 3MM X 10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5832718
• Report Number: 3008881809-2016-00097
• Device Sequence Number: 269706
• Product Code: HCG
• UDI-Device Identifier: 04546540675903
• UDI-Public: (01)04546540675903(17)190531(10)19069474
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K112385
• 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): 07/06/2016

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: 05/31/2019
• Device Catalogue Number: M0035423100
• Device Lot Number: 19069474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2016
• Supplement Report FDA Received Date: 12/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1