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

Catalog Number	M0036181040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during a coil embolization procedure, the physician felt resistance while advancing the coil in the microcatheter, the coil could not be pushed or pulled and the coil unraveled near the detachment zone and had to be retrieved with a 4mm gooseneck snare.The physician replaced it with a new coil and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.Information available indicated that a non-stryker microcatheter was used during the procedure.However, because the device was not returned, a cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during a coil embolization procedure, the physician felt resistance while advancing the coil in the microcatheter, the coil could not be pushed or pulled and the coil unraveled near the detachment zone and had to be retrieved with a 4mm gooseneck snare.The physician replaced it with a new coil and continued the procedure without 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: 7853542
• Report Number: 3008881809-2018-00389
• Device Sequence Number: 13948372
• 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): 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2021
• Device Catalogue Number: M0036181040
• Device Lot Number: 20385445
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 09/21/2018
• 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: VIRTUS MICROCATHETER(BOSTONSCIENTIFIC); VIRTUS MICROCATHETER(BOSTONSCIENTIFIC)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR