MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035424100
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the coil prematurely detached inside the microcatheter.The coil and the microcatheter were removed together as one unit.The procedure was completed successfully and no adverse consequence to the patient was reported.
Additional Manufacturer Narrative
The procedure was completed successfully and no adverse consequence to the patient was reported.The device history record review confirms that the device met all material, assembly and performance specifications.Analysis of the returned device revealed that the main coil was broken/ fractured from the delivery wire, the main coil was extensively stretched and the suture was damaged due to the stretching.In additional the delivery wire was found kinked likely due to handling.Function evaluation was unable to be performed as the main coil was broken/ fractured from the delivery wire.Information available indicated that the device was confirmed to be in good condition prior to use.It is most likely that the main coil sustained damage during the clinical procedure due to some procedural factors contributing to the reported and observed damages.Therefore, an assignable cause of operational context has been assigned to this investigation.
Event or Problem Description
It was reported that during the procedure, the coil prematurely detached inside the microcatheter.The coil and the microcatheter were removed together as one unit.The procedure was completed successfully and no adverse consequence to the patient was reported.

• Brand Name: TARGET 360 ULTRA 4MM 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: 6062647
• Report Number: 3008881809-2016-00236
• Device Sequence Number: 10884514
• Product Code: HCG
• UDI-Device Identifier: 07613252192336
• UDI-Public: (01)07613252192336(17)190531(10)19043199
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K102672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2017

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: 05/30/2019
• Device Catalogue Number: M0035424100
• Device Lot Number: 19043199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2016
• Supplement Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization