MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036101240
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during the procedure the subject coil prematurely detached inside the microcatheter while it was pulled for repositioning.The detached coil was removed with a snare device resulting in a 120 minute surgical delay.No clinical consequences were reported to the patient.
Event or Problem Description
It was reported during the procedure the subject coil prematurely detached inside the microcatheter while it was pulled for repositioning.The detached coil was removed with a snare device resulting in a 120 minute surgical delay.No clinical consequences were reported to the patient.
Additional Manufacturer Narrative
Due to the automated mes/dhr (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 the coil was detached inside the microcatheter while repositioning the coil.No anomalies were noted to the device prior to use and there is no indication of a use error.The anatomy was noted to be of average tortuosity.An assignable cause of undeterminable will be assigned to the reported event of the main coil prematurely detached/separated during use as the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.

• Brand Name: TARGET XL 360 STANDARD 12MM X 45CM
• 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: 22023600
• Report Number: 3008881809-2025-00277
• Device Sequence Number: 13052428
• Product Code: HCG
• UDI-Device Identifier: 04546540711281
• UDI-Public: (01)04546540711281(17)291109(10)25271659
• 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,Followup
• Report Date (Section B): 07/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M0036101240
• Device Lot Number: 25271659
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2024
• 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: SNARE (UNKNOWN).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown