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

Catalog Number	M0035478300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil (subject device) was found to be broken/fractured, stretched, and noted damage to the main coil suture.However, the main coil distal tip was intact.The coil delivery wire was damaged and broken/fractured.A functional inspection could not be performed due to the condition of the returned device.The reported main coil stretch (subject device) was confirmed based on device inspection.The reported detachment failure could not be replicated but the analysis results are consistent with the reported event.The device (subject 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 after multiple detachment attempts the subject coil did not detach.After removal from the microcatheter, the main coil (subject device) was reported to have stretched.The procedure was successfully completed with other stryker coils.The subject device was returned for analysis, and the delivery wire was noted to be extensively damaged.It is likely that this damage contributed to the reported detachment failure.The main coil (subject device) was also noted to be extensively damaged.The subject device was confirmed to be in good condition prior to use, and the anatomy was not considered tortuous.Based on a review of all available information it is probable that procedural factors caused the as reported 'main coil stretched and 'main coil failed/unable to detach' and as analyzed codes 'coil delivery wire damaged', 'coil delivery wire broken/fractured during use', 'main coil stretched', 'main coil broken/fractured during use' and 'main coil suture damage'.This 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.
Event or Problem Description
The coil (subject device) was returned for analysis, and it was revealed that the main coil (subject device) and coil delivery wire (subject device) were 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 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: 23330729
• Report Number: 3008881809-2025-00568
• Device Sequence Number: 18626370
• Product Code: HCG
• UDI-Device Identifier: 04546540676603
• UDI-Public: (01)04546540676603(17)291119(10)25241237
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K242243
• 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): 10/17/2025

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: M0035478300
• Device Lot Number: 25241237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• 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: INZONE POWER SUPPLY (STRYKER); SL-10 MICROCATHETER (STRYKER)
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Race: Asian