MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 7MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036127200
Medical Device Problem Codes	Entrapment of Device (1212); Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure there was resistance while advancing the subject coil inside the catheter.When attempting to withdraw the device from the catheter, it became stretched and detached.The catheter and coil were removed from the patient.A five-minute delay in surgery was reported.The subject coil was replaced and the procedure was completed successfully with no clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
B1 adverse event ¿ corrected ¿ no malfunction.B5 executive summary - updated.H1 type of reportable event: no malfunction.F10/h6 device code grid: corrected.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported during the procedure there was resistance while advancing the subject coil inside the catheter.When attempting to withdraw the device from the catheter, it became stretched and detached.The catheter and coil were removed from the patient.A five-minute delay in surgery was reported.The subject coil was replaced and the procedure was completed successfully with no clinical consequences to the patient due to this event.Additional information received on 06-mar-2025 clarified that the subject coil was detached within the microcatheter outside the patient's body, and not during the procedure as reported.There was no information to reasonably suggest that this type of malfunction would likely cause or contribute to a death or serious injury if the malfunction were to reoccur.Based on the information, this event no longer meets reporting criteria.

• Brand Name: TARGET XL 360 SOFT 7MM X 20CM
• 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: 21521767
• Report Number: 3008881809-2025-00116
• Device Sequence Number: 9560597
• Product Code: HCG
• UDI-Device Identifier: 07613327004632
• UDI-Public: (01)07613327004632(17)270101(10)24687863
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 03/31/2025

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: M0036127200
• Device Lot Number: 24687863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2024
• 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: AXS CATALYST 5 (STRYKER); AXS INFINITY PLUS (STRYKER); EXCELSIOR SL-10 (STRYKER)
• Patient Age: 49 YR
• Patient Sex: Male