MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 4MM X 12CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036124120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The coil (subject device) was returned for analysis, and it was discovered that the main coil (subject device) had suture damage, was stretched and broken/fractured during use.Also, the coil delivery wire was kinked/bent.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 manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was seen to be kinked/bent.The main coil was seen to be fractured from the delivery wire.The main coil was found within the microcatheter and could not be released.It is seen to be kinked and the suture damaged.A functional evaluation could not be performed due to damage.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 inspection.The device failed to meet specifications when received for complaint investigation based on the damage noted to the device.It was reported that as the subject coil advanced more further distal within the microcatheter, the physician met significant resistance.As the physician was removing the coil, the coil appeared stretched and would not completely come out of the microcatheter.During analysis, the coil delivery wire was seen to be kinked/bent.The main coil was seen to be fractured from the delivery wire.The main coil was found within the microcatheter and could not be released.It is seen to be kinked and the suture damaged.Based on a review of all available information and the analysis of the returned device it is probable that the subject coil was damaged during manipulation when the resistance was encountered.An assignable cause of procedural factors will be assigned to the reported event 'coil in catheter friction' and the reported/analysed event of 'main coil stretched' as well as the analysed event of 'coil delivery wire kinked/bent', 'main coil broken/fractured during use' and 'main coil suture damaged' as the 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.

• Brand Name: TARGET XL 360 SOFT 4MM X 12CM
• 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: 23061763
• Report Number: 3008881809-2025-00495
• Device Sequence Number: 9987314
• Product Code: HCG
• UDI-Device Identifier: 07613327128338
• UDI-Public: (01)07613327128338(17)250725(10)23796418
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 09/16/2025

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 Expiration Date: 07/25/2025
• Device Catalogue Number: M0036124120
• Device Lot Number: 23796418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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).; NEUROFORM ATLAS STENT (STRYKER).
• Patient Sex: Unknown