MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 4MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035434150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2025
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 subject coil delivery wire was seen to be kinked.The distal end of the delivery wire was seen to be broken/fractured.The introducer sheath and main coil were intact.A functional test was not carried out due to the damage noted to the device.The reported complaint was confirmed based on device analysis.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 during an aneurysm intervention, a defective coil could not be detached as the delivery wire appeared to be defective.The device was confirmed to be in good condition prior to use and there is no indication of a use error.The device was returned for analysis, and it was noted that the coil delivery wire was broken proximally.A broken delivery wire will not result in successful detachment.Based on the review of all available information, an assignable cause of handling damage will be assigned to the reported 'coil delivery wire damaged', 'main coil failed/unable to detach' and to the analysed 'coil delivery wire kinked/bent 'coil delivery wire broken/fractured during use'.This complaint appears to be associated with handling of the product or portion of the product during the procedure, upon removal of the product from the packaging or preparation of the product prior to use.
Event or Problem Description
The subject coil was returned for analysis, and it was discovered that subject coil delivery wire was broken proximally.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET HELICAL ULTRA 4MM X 15CM
• 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: 23466776
• Report Number: 3008881809-2025-00600
• Device Sequence Number: 21061683
• Product Code: HCG
• UDI-Device Identifier: 04546540676122
• UDI-Public: (01)04546540676122(17)300113(10)25395760
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/04/2025

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: M0035434150
• Device Lot Number: 25395760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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: DETACHMENT DEVICE (UNKNOWN).
• Patient Sex: Unknown