MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 6MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036180640
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The coil (subject device) was returned for analysis and it was discovered that the coil (subject device) was prematurely detached/separated during use.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.During visual inspection, the coil delivery wire was found to be kinked/bent, the main coil was found to be prematurely detached (detached position is unknown), the main coil was found to be kinked/bent, and the suture was found to be intact.During a functional test, the reported 'main coil stretched' was not confirmed based on analysis and the reported 'device difficulty engaging target vessel' could not be confirmed during analysis as the event is procedure/patient related.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.The reported 'main coil stretched' was not confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was analyzed, and the coil delivery wire was found to be kinked/bent.The man coil was found to be kinked/bent and the main was detached prematurely.An assignable cause of not confirmed will be assigned to the reported 'main coil stretched' and 'device difficulty engaging target vessel' as the issue was not confirmed during device analysis.An assignable cause of handing damage will be assigned to the as analyzed code 'coil delivery wire kinked/bent' as this defect appears to be associated with handling of the product or portion of the product during the procedure.An assignable cause of procedural factors will be assigned to the as analyzed 'main coil kinked/bent' and 'main coil prematurely detached/separated during use' since these issues appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.

• Brand Name: TARGET XXL 360 6MM X 40CM
• 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: 16401199
• Report Number: 3008881809-2023-00072
• Device Sequence Number: 20112230
• Product Code: HCG
• UDI-Device Identifier: 07613327466409
• UDI-Public: 07613327466409
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 02/17/2023

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: 11/27/2024
• Device Model Number: M0036180640
• Device Catalogue Number: M0036180640
• Device Lot Number: 23340844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• 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 1018 MICROCATHETER (STRYKER); TARGET COILS (STRYKER)
• Patient Sex: Unknown