MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035432080
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2019
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 an embolization procedure for an aneurysm, the coil (subject device) was repositioned several times and prematurely detached.The procedure was ended with the coil protruding from the parent vessel.The physician used the microcatheter to push the coil inside and the patient was given antiplatelets to prevent clotting around the pre-detached coil.No further information is available at this time.
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 the device was confirmed to be in good condition prior to use.The reported event is covered in the device directions for use (dfu).The risk of the reported event has been addressed in the risk documentation and there are current controls in place to mitigate the risk of the as reported event.Based on the information currently available, the exact cause for the reported event cannot be determined.
Event or Problem Description
It was reported that during an embolization procedure for an aneurysm, the coil (subject device) was repositioned several times and prematurely detached.The procedure was ended with the coil protruding from the parent vessel.The physician used the microcatheter to push the coil inside and the patient was given antiplatelets to prevent clotting around the pre-detached coil.No further information is available at this time.

• Brand Name: TARGET HELICAL ULTRA 2MM X 8CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8458549
• Report Number: 3008881809-2019-00082
• Device Sequence Number: 3057667
• Product Code: HCG
• UDI-Device Identifier: 04546540676023
• UDI-Public: 04546540676023
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2021
• Device Catalogue Number: M0035432080
• Device Lot Number: 20390197
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/23/2019
• 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: ECHELON MICROCATHETER(MEDTRONIC)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 75 YR