MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035424080
Medical Device Problem Code	No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported after the embolization was performed and the subject coil was released for placement, it could not be observed under fluoroscopy.The procedure was completed with no clinical consequences to the patient.No further information is available.
Event or Problem Description
It was reported after the embolization was performed and the subject coil was released for placement, it could not be observed under fluoroscopy.The procedure was completed with no clinical consequences to the patient.No further information is available.
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.During visual inspection the coil proximal contact was seen to be kinked/bent.The coil delivery wire was found to be kinked/bent in multiple areas.The main coil was prematurely detached /separated.The main coil was not returned.Functional testing was unable to perform as the main coil 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.The reported complaint could not be confirmed as the main coil was not returned for analysis.Only the delivery wire was received.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that at the time of detachment, the coil was not visible to the physician.The coil was confirmed to be in good condition prior to use.The microcatheter was checked after removal and no detached coil was observed.Only the delivery wire was returned for complaint analysis.It was confirmed that the coil had separated from the delivery wire at the detachment zone.It cannot be confirmed if the detachment happened during introduction or removal of the coil.It also cannot be confirmed if the coil was visible under x-ray as the coil was not returned.An assignable cause of undeterminable will be assigned to the as reported event of the device or device component not visible under fluoroscopy and main coil prematurely detached/separated during use.The review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.An assignable cause of handling damage will be assigned to the as analyzed damage of the coil delivery wire kinked/bent and coil proximal contact kinked/bent as the issue is due to handling of the product or portion of the product without direct patient contact during shipping/transportation.

• Brand Name: TARGET 360 ULTRA 4MM X 8CM
• 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: 21411909
• Report Number: 3008881809-2025-00093
• Device Sequence Number: 15780853
• Product Code: HCG
• UDI-Device Identifier: 04546540675927
• UDI-Public: (01)04546540675927(17)291008(10)25218558
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K120850
• 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): 05/01/2025

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: M0035424080
• Device Lot Number: 25218558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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
• Patient Sex: Male