MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036126200
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the coil embolization procedure with a double catheter technique, the physician placed two coils into the aneurysm and attempted to detach the coil with the detachment system.However, one of the coils was detached into the aneurysm, but the detachment system was not able to detect the subject coil delivery wire and could not be detached into the aneurysm.The physician replaced the detachment system with another one and attempted to detach the subject coil, but still, the issue remains.On withdrawing the subject coil from the patient's anatomy, resistance was felt inside the microcatheter due to this the subject coil was prematurely detached inside the microcatheter.Further, the physician pushed the subject coil into the aneurysm by the delivery wire.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.No visual or functional inspection was performed due to 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.Additional information provided by the customer was after the subject coil was placed it failed to detach, the coil was then retracted from the catheter but due to resistance encountered the coil prematurely detached inside the catheter.In the follow-up gfe questions it was reported that the device was prepared as per the dfu, that there was no damage noted to the packaging prior to opening and the device was confirmed to be in good condition during preparation/prior to use on the patient, and that continuous flush was set up and maintained during the procedure.While there are a number of potential causes for the as reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to this complaint.
Event or Problem Description
It was reported that during the coil embolization procedure with a double catheter technique, the physician placed two coils into the aneurysm and attempted to detach the coil with the detachment system.However, one of the coils was detached into the aneurysm, but the detachment system was not able to detect the subject coil delivery wire and could not be detached into the aneurysm.The physician replaced the detachment system with another one and attempted to detach the subject coil, but still, the issue remains.On withdrawing the subject coil from the patient's anatomy, resistance was felt inside the microcatheter due to this the subject coil was prematurely detached inside the microcatheter.Further, the physician pushed the subject coil into the aneurysm by the delivery wire.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XL 360 SOFT 6MM 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: 13873573
• Report Number: 3008881809-2022-00135
• Device Sequence Number: 11935212
• Product Code: HCG
• UDI-Device Identifier: 07613327004625
• UDI-Public: 07613327004625
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153658
• 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): 06/07/2022

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: 08/31/2024
• Device Model Number: M0036126200
• Device Catalogue Number: M0036126200
• Device Lot Number: 23136046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• 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: INZONE DETACHMENT SYSTEM (STRYKER)
• Patient Sex: Unknown