MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 14MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036181450
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure when the subject coil was advanced in the microcatheter there was resistance and one subject coil prematurely detached inside the catheter.The physician removed the subject coil and it was replaced.The procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot 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 the coil prematurely detached in the catheter.Additional information provided by the customer indicated that the device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.The device was confirmed to be in good condition during preparation/ prior to use on the patient.Intermittent flush was set up and maintained throughout the clinical procedure.The patient's anatomy was severely tortuous, and this is insufficient evidence to determine if this was the cause for the reported events.An assignable cause of undeterminable will be assigned reported event of the main coil prematurely detached/separated during use and coil in catheter friction 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 during the procedure when the subject coil was advanced in the microcatheter there was resistance and one subject coil prematurely detached inside the catheter.The physician removed the subject coil and it was replaced.The procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: TARGET XXL 360 14MM X 50CM
• 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: 21286899
• Report Number: 3008881809-2025-00063
• Device Sequence Number: 9320122
• Product Code: HCG
• UDI-Device Identifier: 07613327128383
• UDI-Public: (01)07613327128383(17)260307(10)24211171
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161429
• 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): 03/17/2025

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: 03/07/2026
• Device Catalogue Number: M0036181450
• Device Lot Number: 24211171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2023
• 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: (2) COILS (STRYKER); MICROCATHETER (UNKNOWN)
• Patient Sex: Prefer Not To Disclose