MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 8MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036180840
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
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 seen to be kinked/bent.The delivery wire was found to be broken/fractured at the detachment zone.The main coil was found to be kinked/bent in multiple area.During functional inspection, the reported 'coil in catheter friction' could not be replicated as the delivery wire was retuned broken/fractured at the detachment zone, however, the analysis results are consistent with the reported event.The reported 'main coil stretched' was not confirmed.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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 the subject coil was difficult to be advanced due to resistance in the shaft.When retrieved the subject coil along with the entire microcatheter it was found to be stretched.Additional information provided by the customer indicated that the device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.The device was confirmed to be in good condition during preparation/ prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure.The patient's anatomy was severely tortuous.An assignable cause of not confirmed will assigned to as reported 'main coil stretched' as the reported issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of the defect which could have contributed to the event.An assignable cause of procedural factors will be assigned to as reported 'coil in catheter friction', as well as analyzed 'main coil kinked/bent' and 'coil delivery wire broken/fractured during use' as the complaint appears 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 factors during use.An assignable cause of handling damage will be assigned to as analyzed 'coil delivery wire kinked/bent' because this complaint appears to be associated with handling of the product or portion of the product during the procedure.
Event or Problem Description
The subject coil was returned for analysis and it was discovered that the subject coil delivery wire was broken/fractured during use.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XXL 360 8MM 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: 22137283
• Report Number: 3008881809-2025-00313
• Device Sequence Number: 18014100
• Product Code: HCG
• UDI-Device Identifier: 07613327466423
• UDI-Public: (01)07613327466423(17)270624(10)24945107
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K242243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2025

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 Catalogue Number: M0036180840
• Device Lot Number: 24945107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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: (ASAHI INTEC MICROCATHETER (NON-STRYKER)
• Patient Sex: Unknown