MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036121040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the subject coil was used for embolization of an arteriovenous shunt due to interruption of shunt blood flow after the surgery, the subject coil was inserted into the body; however, it was retrieved because it was undersized for the target site.After implanting an oversized coil, the subject coil was attempted to be reinserted.Although the assistant doctor kinked the proximal part of the subject coil delivery wire, when retracting the subject coil into the sheath, it was used as it was.Resulted prematurely detachment of the delivery wire when 2/3 of the total length of the subject coil was inserted.The delivery wire was retrieved as it was because there was a prematurely detached part of the proximal part of the delivery wire in the hub of the microcatheter.The subject coil was safely removed from the body without stretching.It was also, reported that the subject coil encountered resistance inside the catheter.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
Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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 device was intended to be used for treatment.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.It was reported that delivery wire fractured at a proximal location.It was noted that the coil was able to be moved with resistance.The coil was retrieved and the case was successfully completed with a different device.Additional information provided by the customer indicated that the device was confirmed to be in good condition prior to use.Continuous flush was not maintained which may have contributed to the reported friction.The anatomy was also noted to be severely tortuous.An assignable cause of undeterminable will be assigned to the as reported 'coil in catheter friction' and 'coil delivery wire broken/fractured 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.
Event or Problem Description
It was reported that when the subject coil was used for embolization of an arteriovenous shunt due to interruption of shunt blood flow after the surgery, the subject coil was inserted into the body; however, it was retrieved because it was undersized for the target site.After implanting an oversized coil, the subject coil was attempted to be reinserted.Although the assistant doctor kinked the proximal part of the subject coil delivery wire, when retracting the subject coil into the sheath, it was used as it was.Resulted prematurely detachment of the delivery wire when 2/3 of the total length of the subject coil was inserted.The delivery wire was retrieved as it was because there was a prematurely detached part of the proximal part of the delivery wire in the hub of the microcatheter.The subject coil was safely removed from the body without stretching.It was also, reported that the subject coil encountered resistance inside the catheter.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XL 360 SOFT 10MM X 40CM
• 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: 20862537
• Report Number: 3008881809-2024-00579
• Device Sequence Number: 18290820
• Product Code: HCG
• UDI-Device Identifier: 07613327004601
• UDI-Public: (01)07613327004601(17)260731(10)24447548
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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: 07/31/2026
• Device Catalogue Number: M0036121040
• Device Lot Number: 24447548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown