MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 3MM X 9CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036123090
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	08/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the main coil (subject device) was stuck at the distal portion of the microcatheter.The physician tried to retrieved by applying negative pressure with a syringe, but the coil could not be removed.After that, it was caught with snare and retrieved with microcatheter and the procedure was completed successfully.There are no known clinical consequences to the patient at this time.
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.Visual and microscopic inspection of the device found that the coil delivery wire was kinked and the main coil was stretched.The main coil was noted to be detached from the pusher wire electronically.Functional test could not be performed due to the damaged condition of the device.It is possible that coil delivery wire was damaged during the procedure as force may have been applied when the friction was felt during the procedure.Based on the available information, the patient¿s anatomy was severely tortuous.It is probable that when the coil was being re-positioned through the catheter that the medical intervention would have taken place.Therefore, an assignable cause of procedural factor has been assigned to the as reported issue.
Event or Problem Description
It was reported that during the procedure, the main coil (subject device) was stuck at the distal portion of the microcatheter.The physician tried to retrieved by applying negative pressure with a syringe, but the coil could not be removed.After that, it was caught with snare and retrieved with microcatheter and the procedure was completed successfully.There are no known clinical consequences to the patient at this time.

• Brand Name: TARGET XL 360 SOFT 3MM X 9CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8942791
• Report Number: 3008881809-2019-00255
• Device Sequence Number: 2041345
• Product Code: HCG
• UDI-Device Identifier: 07613327128284
• UDI-Public: 07613327128284
• 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): 10/24/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2022
• Device Catalogue Number: M0036123090
• Device Lot Number: 21122746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 10/24/2019
• 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: NADESHIKO MICROCATHETER (JMS)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR