MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 1CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035431010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The coil (subject device) was returned for analysis and the device investigation revealed that the main coil 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.
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 main coil was seen to be broken/fractured, the coil delivery wire was seen to be kinked/bent, the main coil suture was seen to be damaged and the main coil was stretched, and the introducer sheath was intact.A functional inspection was not performed.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 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.It was reported that the coil did not unfold during a procedure.The procedure was completed with another helical coil.The device was returned for analysis, and it was noted that the coil was stretched and fractured.Additional information indicates that the device was in good condition prior to use and there is no indication of a use error.It is likely that the coil was damaged during use resulting in the reported event.An assignable cause of procedural factors will be assigned to the reported code 'device difficulty engaging target vessel' and to the analyzed codes '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.An assignable cause of handling damage will be assigned to the analyzed code, 'coil delivery wire kinked/bent'.The issue appears to be due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.

• Brand Name: TARGET HELICAL NANO 1MM X 1CM
• 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: 23482557
• Report Number: 3008881809-2025-00609
• Device Sequence Number: 18766797
• Product Code: HCG
• UDI-Device Identifier: 04546540700216
• UDI-Public: (01)04546540700216(17)251106(10)24006441
• 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): 11/05/2025

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 Expiration Date: 11/06/2025
• Device Catalogue Number: M0035431010
• Device Lot Number: 24006441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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: SL-10 CATHETER (STRYKER)
• Patient Sex: Unknown