MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 9MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036129300
Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 2 of 2 reports.Device not returned.
Event or Problem Description
It was reported that, during coil embolization for internal carotid artery-posterior communicating artery (ic-pc) ruptured aneurysm, after implanting a first coil (the subject device) for framing the aneurysm, a second coil was inserted using a second microcatheter, but still attached to the delivery wire.The second coil became tangled with the first coil and both were removed from the patient's body using one microcatheter.The physician was able to untangle the coils; however, the coils were broken while outside the patient's body.The procedure was completed with another coil.There were no clinical consequences reported due to this event.
Event or Problem Description
It was reported that, during coil embolization for internal carotid artery-posterior communicating artery (ic-pc) ruptured aneurysm, after implanting a first coil (the subject device) for framing the aneurysm, a second coil was inserted using a second microcatheter, but still attached to the delivery wire.The second coil became tangled with the first coil and both were removed from the patient's body using one microcatheter.The physician was able to untangle the coils; however, the coils were broken while outside the patient's body.The procedure was completed with another coil.There were no clinical consequences reported due to this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.In case of this complaint, it is possible that the main coil tangled while getting retrieved from the micorcatheter and later broke due to some procedural factors encountered during use, possibly leading to the as reported issues; however, cannot be confirmed.Based on the additional information provided by the customer, no damage was noted to the coil prior to use and the device was prepared as per direction for use (dfu); therefore, an assignable cause of undetermined was assigned to the as reported issues 'nv ¿ main coil tangled', and 'nv ¿ coil broken/fractured', as the device was not returned, and the review and analysis of all available information failed to indicate as assignable cause.

• Brand Name: TARGET XL 360 SOFT 9MM X 30CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8076139
• Report Number: 3008881809-2018-00491
• Device Sequence Number: 1616329
• Product Code: HCG
• UDI-Device Identifier: 04546540711618
• UDI-Public: 04546540711618
• Combination Product (Y/N): N
• PMA/510(K) Number: K153658
• 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): 12/17/2018

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: 09/30/2019
• Device Catalogue Number: M0036129300
• Device Lot Number: 19447686
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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: TARGET COIL (STRYKER)