MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035474150
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when about 3cm of the main coil was remaining be advanced inside the aneurysm, the coil was repositioned; however, resistance was felt and the coil was stuck inside the aneurysm.While the physician was attempting to retrieve the coil, the proximal part of the coil stretched and it was mechanically detached inside the microcatheter.The physician removed the detached coil along with the microcatheter from the patient's body without clinical consequence to the patient.
Additional Manufacturer Narrative
Expiration date/manufacturing date: added.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Device visual and microscopic evaluation revealed that the main coil was stretched and physically detached from the delivery wire.In addition, the proximal contact was bent, most likely, due to the handling of the device during use.During functional testing, the returned codman microcatheter inner diameter was measured as 0.022", which was above the recommended internal diameter.The target direction for use (dfu) states the following: "target detachable coils are compatible with stryker neurovascular 2-tip marker microcatheters (min.Internal diameter 0.41 mm [0.016 in], max.Internal diameter 0.48 mm [0.019 in])¿.It is likely, that larger inner diameter microcatheter may have caused the buckling of the main coil within the lumen of the microcatheter resulting in the as reported friction, consequent stretching and detachment of the coil.Information from the complaint indicated that the coil was in good condition prior to use and was prepared as per dfu.Therefore, based on the device analysis and information available, an assignable cause of use error has been assigned to this investigation.
Event or Problem Description
It was reported that when about 3 cm of the main coil was remaining to be advanced inside the aneurysm, the coil was repositioned; however, resistance was felt and the coil was stuck inside the aneurysm.While the physician was attempting to retrieve the coil, the proximal part of the coil stretched and it was mechanically detached inside the microcatheter.The physician removed the detached coil along with the microcatheter from the patient's body without clinical consequence to the patient.

• Brand Name: TARGET 360 SOFT 4MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6176134
• Report Number: 3008881809-2016-00307
• Device Sequence Number: 358839
• Product Code: HCG
• UDI-Device Identifier: 04546540676481
• UDI-Public: (01)04546540676481(17)190131(10)18786471
• Combination Product (Y/N): N
• 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): 04/12/2017

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: 01/31/2019
• Device Catalogue Number: M0035474150
• Device Lot Number: 18786471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 04/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (CODMAN)