MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036181040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during coil embolization of an aneurysm located on the internal iliac artery, the coil (subject device) was prematurely detached at the detachment zone.The coil proximal tail was still inside the microcatheter when the premature detachment occurred and half of the coil was outside the microcatheter.The coil was removed with the microcatheter as one unit.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual examination of the returned device revealed that the delivery wire was kinked/bent likely due to handling damage that limited the performance of the device during the procedure.I was also noted that the main coil was prematurely detached/separated due to a physical break at the detachment zone.Based on the information received, the main coil was confirmed to have detached due to a physical break at the detachment zone, and the tortuosity of the anatomy was noted to be severe.It is likely that the device was damaged during use resulting in the reported prematurely detachment.An assignable cause of procedural factors will be assigned to this reported and analyzed prematurely detachment.Expiration date: updated.Device evaluated by mfg: updated.Summary attached: added.Manufacturing date: updated.
Event or Problem Description
It was reported that during coil embolization of an aneurysm located on the internal iliac artery, the coil (subject device) was prematurely detached at the detachment zone.The coil proximal tail was still inside the microcatheter when the premature detachment occurred and half of the coil was outside the microcatheter.The coil was removed with the microcatheter as one unit.There were no clinical consequences to the patient.

• Brand Name: TARGET XXL 360 10MM X 40CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7700503
• Report Number: 3008881809-2018-00310
• Device Sequence Number: 903665
• Product Code: HCG
• UDI-Device Identifier: 07613327128406
• UDI-Public: 07613327128406
• Combination Product (Y/N): N
• PMA/510(K) Number: K161429
• 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): 09/24/2018

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: 03/11/2021
• Device Catalogue Number: M0036181040
• Device Lot Number: 20371936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1