MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil (subject device) was used in the medical procedure.However, the subject coil got broke off within the microcatheter.The patient was not affected.No further information available.
Event or Problem Description
It was reported that the coil (subject device) was used in the medical procedure.However, the subject coil got broke off within the microcatheter.The surgery was delayed by 10 minutes.The subject device was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient.
Additional Manufacturer Narrative
B1 - product problem - corrected - no product problem.B5 - executive summary - updated.D4 ¿ expiration date ¿ added.D4 ¿ gtin ¿ updated.D9 - product available to stryker - updated.D9 - returned to manufacturer on ¿ updated.E1 - initial reporter phone ¿ updated.E1 - initial reporter address ¿ updated.E1 - initial reporter city - updated.H1 type of reportable event - corrected - no malfunction.H3 - device evaluated by mfg ¿ updated.H4 ¿ manufacturing date - added.F10/h6 health effect - impact code - updated.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, there was no damage noted to the coil.Functional inspection was not required as the device was intact and no anomalies were 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 reported event of ¿main coil broken/fractured during use¿ was not confirmed during analysis.It was reported that the coil broke off in the microcatheter.The patient was not affected but the case became much more difficult due to having to take the catheter out and re-access the vessel.The device was returned for analysis, and it was noted that the main coil was intact and the coil was still attached to the delivery wire.Based on a review of all available information and the analysis of the returned device an assignable cause of not confirmed will be assigned to the reported event of ¿main coil broken/fractured during use¿.The issue included a returned device review (visual, physical testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TARGET 360 ULTRA 3MM X 4CM
• 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: 23354568
• Report Number: 3008881809-2025-00573
• Device Sequence Number: 21073966
• Product Code: HCG
• UDI-Device Identifier: 04546540675873
• UDI-Public: (01)04546540675873(17)300706(10)25717917
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 12/22/2025

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: M0035423040
• Device Lot Number: 25717917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2025
• 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: MICROCATHETER (UNKNOWN).
• Patient Sex: Unknown