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

Catalog Number	M0036181040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil (subject device) was used in the medical procedure.However, resistance was encountered at the proximal end of microcatheter when the subject coil was inserted.Also, the subject coil got prematurely detached within the microcatheter when the physician attempted to pull it back.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient.
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.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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 during coil embolization; while inserting the coil into a microcatheter, resistance was encountered at the proximal end of the microcatheter.When the coil was pulled back it detached prematurely in the microcatheter.The coil was replaced with another coil of the same kind, and the procedure was completed successfully.Additional information provided by the customer indicated that there was no friction noted inside the introducer sheath.The microcatheter used was noted to have an id (internal diameter) which is larger than the recommended max id of 0.019inch.This is likely to have contributed to the friction and subsequent detachment.Based on review of all available information an assignable cause of use error will be assigned to this complaint as the investigation confirms that there was the use of an incorrectly sized product; a deviation from the supplied dfu that resulted in a different medical product response than intended by the manufacturer or expected by the user.
Event or Problem Description
It was reported that the coil (subject device) was used in the medical procedure.However, resistance was encountered at the proximal end of microcatheter when the subject coil was inserted.Also, the subject coil got prematurely detached within the microcatheter when the physician attempted to pull it back.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient.

• Brand Name: TARGET XXL 360 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: 23610407
• Report Number: 3008881809-2025-00653
• Device Sequence Number: 18588250
• Product Code: HCG
• UDI-Device Identifier: 07613327128406
• UDI-Public: (01)07613327128406(17)300426(10)25589269
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: M0036181040
• Device Lot Number: 25589269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2025
• 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: LANTERN MICROCATHETER (NON-STRYKER)
• Patient Age: 78 YR
• Patient Sex: Male