MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 3MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035473100
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during deployment of a coil, the successfully detached subject coil got entangled with the microcatheter and came out when the microcatheter was pulled back.The subject device was withdrawn and was replaced with a different coil and catheter.The procedure was completed successfully with a delay of 10 mins.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
C2/d10 concomitant products grid ¿ added.H3 device evaluated by mfg ¿ 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, it was noted that the coil delivery wire was not returned.The main coil was found to be kinked/bent.The main coil was found to be tangled.Also, the main coil was found to be detached /separated from the delivery wire.During functional inspection, it was noted that the main coil was returned with the microcatheter used in the procedure and tangled with the coil.The coils were separated during the analysis.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 returned 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 during the placement of a second coil, the previously placed coil became tangled with the microcatheter and was pulled out of the aneurysm.It was removed with the microcatheter.No issues were reported during placement of the first coil.The device was confirmed to be in good condition prior to use and appears to have been used in accordance with the dfu.Based on the review of all available information, an assignable cause of procedural factors was assigned to the as reported ¿main coil tangled¿, ¿device interaction with another device¿ and ¿main coil migration¿ as well as to the as analyzed ¿main coil kinked/bent¿ and ¿main coil tangled¿ codes.The issue is associated with a product that meets stryker design and manufacture specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during deployment of a coil, the successfully detached subject coil got entangled with the microcatheter and came out when the microcatheter was pulled back.The subject device was withdrawn and was replaced with a different coil and catheter.The procedure was completed successfully with a delay of 10 mins.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 SOFT 3MM X 10CM
• 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: 21749032
• Report Number: 3008881809-2025-00176
• Device Sequence Number: 3993516
• Product Code: HCG
• UDI-Device Identifier: 07613252239475
• UDI-Public: (01)07613252239475(17)290820(10)25085502
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 05/15/2025

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: M0035473100
• Device Lot Number: 25085502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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: EXCELSIOR SL - 10 MICROCATHETER (STRYKER); EXCELSIOR SL-10 MICROCATHETER (STRYKER); SYNCHRO 14 GUIDEWIRE (STRYKER); SYNCHRO 14 GUIDEWIRE (STRYKER); TARGET COIL (STRYKER)
• Patient Sex: Unknown