MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035478300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/19/2022
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 the procedure, the subject coil was stretched at the distal part upon deployment, and it could not be advance or retrieved inside the microcatheter.The physician applied force to remove the coil (subject device) but the main coil was fractured and was left inside the anatomy.A snare was used to retrieve the fragment but removal was not successful.There was a 40 mins delay during the procedure to remove the coil.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection, as well as a functional evaluation, could not be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.It was reported that during the procedure coil stretched upon attempted deployment into aneurysm.Microcatheter and coil would not advance forward or backward.Physician was forced to remove microcatheter and leave coil tail in patient.Additional information provided by the customer indicated that there was surgical delay of 40 minutes.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during the procedure, the subject coil was stretched at the distal part upon deployment, and it could not be advance or retrieved inside the microcatheter.The physician applied force to remove the coil (subject device) but the main coil was fractured and was left inside the anatomy.A snare was used to retrieve the fragment but removal was not successful.There was a 40 mins delay during the procedure to remove the coil.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 SOFT 8MM X 30CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 13831778
• Report Number: 3008881809-2022-00126
• Device Sequence Number: 991468
• Product Code: HCG
• UDI-Device Identifier: 04546540676603
• UDI-Public: 04546540676603
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 04/27/2022

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: 06/20/2024
• Device Model Number: M0035478300
• Device Catalogue Number: M0035478300
• Device Lot Number: 22978154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 03/20/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female