MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 2.5MM X 3.5CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5412535
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2026
Type of Reportable Event	Malfunction
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.
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 noted to be kinked/bent.The distal end of delivery wire was noted to be broken/fractured.The main coil was noted to be kinked and stretched.The introducer sheath was not returned.A functional inspection was not carried out due to the damage 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.The as reported 'main coil failed/unable to detach' it could not be replicated during device analysis; however, the analysis results are consistent with the reported event.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 subject coil was placed at the aneurysm, and the physician attempted to detach it using a detacher device however, the detachment failed despite multiple attempts.The detacher was then replaced, but the issue persisted.To successfully complete the surgery, both the subject coil and the detacher were replaced.The returned device was analyzed, and it was found that the coil delivery wire was kinked and bent at several points.It was also observed that the distal end of the coil was broken/fractured.Additionally, the main coil appeared to be kinked and stretched.The introducer sheath was not returned with the device.Additional information provided by the customer indicated that the delivery wire was broken at the proximal contact.It was also reported that the device was not wiped with alcohol prior to insertion into the power supply.Multiple attempts were made to detach the subject coil, during which the device may have been pushed and pulled against resistance.These factors may be the probable cause of the reported event 'main coil failed/unable to detach', and the analyzed events, including 'coil delivery wire broken/fractured during use', 'main coil kinked/bent' and 'main coil stretched.' an assignable cause of 'use error' will be assigned to 'main coil failed/unable to detach' since there was a deviation from the supplied dfu that resulted in a different medical product response than intended by the manufacturer or expected by the user.An assignable cause of 'procedural factors' will be assigned to this analyzed code including 'coil delivery wire broken/fractured during use', 'main coil kinked/bent' and 'main coil stretched' as 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 as analyzed 'coil delivery wire kinked/bent' since this issue is most likely 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 TETRA 2.5MM X 3.5CM
• 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: 25097462
• Report Number: 3008881809-2026-00280
• Device Sequence Number: 15942527
• Product Code: HCG
• UDI-Device Identifier: 07613327578614
• UDI-Public: (01)07613327578614(17)260910(10)24517599
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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: 09/10/2026
• Device Catalogue Number: TG5412535
• Device Lot Number: 24517599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• 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).
• Patient Sex: Unknown