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

Catalog Number	M0035422040
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during a coil embolization procedure, the coil detached "precosiously" in the microcatheter and not into the aneurysm.The user facility was requested to provide additional information in regards to the event; however, as of today, no further information is available.
Additional Manufacturer Narrative
Product available - corrected.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The coil was returned along with the microcatheter used (echelon microcatheter by ev3).Blood was observed inside the echelon microcatheter hub and inside the coil introducer sheath.Analysis of the returned coil revealed that the main coil had physically detached from the delivery wire at the detachment zone and it was found inside the hub of the returned microcatheter.The main coil was removed from the hub and was found to be tangled and broken at the proximal end.In addition the main coil had a kinked.Based on the results of the dhr review, there is no indication that the device, labelling or packaging failed to meet its specifications when released.In the case of the reported event, the main coil most likely stretched, tangled and then broke/fractured at the proximal end inside the microcatheter during the procedure.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 stretched, tangled and detached at the detachment zone.In the case of this complaint it is possible that insufficient flush was used during the clinical procedure as blood was noted inside the microcatheter and inside the introducer sheath.This however cannot be conclusively determined.Information available indicated that the device was confirmed by the user to be in good condition prior to use.Based on the information available and analysis of the device the exact cause that led to the reported and analyzed damages on the main coil cannot be determined.
Event or Problem Description
It was reported that during a coil embolization procedure, the coil detached "precosiously" in the microcatheter and not into the aneurysm.The user facility was requested to provide additional information in regards to the event; however, as of today, 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 NA
• MDR Report Key: 5881439
• Report Number: 3008881809-2016-00124
• Device Sequence Number: 11066986
• Product Code: HCG
• UDI-Device Identifier: 04546540675842
• UDI-Public: (01)04546540675842(17)190131(10)18789255
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2016

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: 01/31/2019
• Device Catalogue Number: M0035422040
• Device Lot Number: 18789255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2016
• Supplement Report FDA Received Date: 12/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR