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

Catalog Number	M0036124120
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during coil embolization of subarachnoid hemorrhage (sah) procedure, the operator implanted six coils using a guidewire and a microcatheter.The subject coil was attempted to be placed as the seventh coil; however, while repositioning, the subject coil could not to be moved as intended.The operator attempted to retrieve the subject coil, which caused a premature detachment.The subject coil was removed using a goose neck snare.Upon retrieval, the subject coil was found to be stretched.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.D4 gtin - updated.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the coil was returned attached to a snare device.The delivery wire or introducer sheath were not returned.The coil was stretched proximally.Significant procedural fluid was noted on the device.The coil delivery wire was separated from the coil due to a break at the detachment zone.Functional inspection was not performed due to the damage 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 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 while repositioning the seventh coil in the aneurysm, the operator felt the coil had stretched.In attempt to retrieve the coil, the coil detached.The coil was removed with a snare and the case was completed successfully without adding another coil.The device was returned for analysis, and it was noted that the coil was stretched on the proximal end and had detached mechanically at the detachment zone.An assignable cause of procedural factors will be assigned to the reported events: ¿main coil stretched¿ and ¿main coil prematurely detached/separated during use¿ as well as analyzed events: ¿main coil stretched¿ and ¿main coil prematurely detached/separated during use¿ 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.
Event or Problem Description
It was reported that during coil embolization of subarachnoid hemorrhage (sah) procedure, the operator implanted six coils using a guidewire and a microcatheter.The subject coil was attempted to be placed as the seventh coil; however, while repositioning, the subject coil could not to be moved as intended.The operator attempted to retrieve the subject coil, which caused a premature detachment.The subject coil was removed using a goose neck snare.Upon retrieval, the subject coil was found to be stretched.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• 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: 22359755
• Report Number: 3008881809-2025-00362
• Device Sequence Number: 7998069
• Product Code: HCG
• UDI-Device Identifier: 07613327128338
• UDI-Public: (01)07613327128338(17)270825(10)25090640
• 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): 07/30/2025

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: M0036124120
• Device Lot Number: 25090640
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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: SL-10 MICROCATHETER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male