MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil proximal contact was seen to be kinked, the coil delivery wire was seen to be kinked, the main coil was seen to be fractured, and the main coil was seen to be stretched and the suture damaged.A functional inspection was unable to be performed; main coil was returned in the catheter.Upon removal, damage was noted.The reported event of 'coil in catheter friction' could not be replicated; 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.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.Additional information provided by the customer, the physician employed a microcatheter for coil delivery.When there was approximately 1/5 of the coil still inside the microcatheter during delivery, the physician was unable to smoothly push the remaining part of the coil out of the microcatheter.Subsequently, the physician withdrew the coil, trimmed 2 cm from its tip, and attempted delivery again.However, after delivering 4/5 of the coil this time, the physician was still unable to completely push it out of the microcatheter.The patient's anatomy was moderately tortuous.The device was analysed and the proximal contact was kinked along with the coil delivery wire, proving friction was noted, the main coil was fractured just after the glue bond, and the main coil was severely damaged.It is probable the patient's anatomy or the defects noted to the device contributed to the failure.Based on review of all available information an assignable cause of procedural factors will be assigned to the reported event of 'coil in catheter friction' as these defects 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 procedural factors will be assigned to the analysed events of 'main coil broken/fractured during use', 'main coil stretched' and 'main coil suture damaged' as these defects 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 analysed events of 'coil proximal contact kinked/bent and coil delivery wire kinked/bent' as the defect appears to be associated with handling of the product or portion of the product during preparation.
Event or Problem Description
The coil (subject device) was returned for analysis, and it was discovered that the subject coil had suture damage, it was stretched and was broken/fractured during use.Also, the delivery wire and the proximal contact of the subject coil was kinked/bent.The subject device was reported to be replaced, and the procedure was reported to be completed successfully.No clinical consequences were reported to the patient.

• Brand Name: TARGET 360 ULTRA 3MM X 8CM
• 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: 25257268
• Report Number: 3008881809-2026-00332
• Device Sequence Number: 18775505
• Product Code: HCG
• UDI-Device Identifier: 04546540675897
• UDI-Public: (01)04546540675897(17)300809(10)25772711
• 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): 05/22/2026

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 Catalogue Number: M0035423080
• Device Lot Number: 25772711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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: ECHELON 14 MICROCATHETER (NON-STRYKER).
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Race: Asian