MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036122060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure, the subject coil which was inserted as the tenth coil out of thirteen, was difficult to engage in the aneurysm and the physician had to reposition it several times.When the physician attempted to retrieve the subject coil, it was confirmed that the subject coil prematurely detached within the microcatheter and could not be removed.The subject coil was pushed into the aneurysm with the next coil and the procedure was completed successfully using the same microcatheter.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during the procedure, the subject coil which was inserted as the tenth coil out of thirteen, was difficult to engage in the aneurysm and the physician had to reposition it several times.When the physician attempted to retrieve the subject coil, it was confirmed that the subject coil prematurely detached within the microcatheter and could not be removed.The subject coil was pushed into the aneurysm with the next coil and the procedure was completed successfully using the same microcatheter.No clinical consequences were reported to the patient due to this event.
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 is not available; therefore, functional testing as well as visual testing cannot be performed.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, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared for use as per the dfu (except continuous flush was not set up and maintained throughout the clinical procedure), the tortuosity of the patient's anatomy was normal, the tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter, the whole coil was fully detached from the delivery wire, no attempt was made to detach the subject coil using a power supply, the prematurely detached coil was pushed into the aneurysm with the next coil, and the procedure was completed successfully using the same microcatheter.In the case of this complaint, it is probable that lack of continuous flush contributed to the reported event.Per the dfu: "in order to achieve optimal performance of the detachable coil system and to reduce the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate flush solution be maintained between a) the femoral sheath and guiding catheter, b) the 2-tip microcatheter and guiding catheters, and c) the 2-tip microcatheter and stryker neurovascular guidewire and delivery wire.Continuous flush also reduces the potential for thrombus formation on, and crystallization of infusate around, the detachment zone of the detachable coil".An assignable cause of use error will be assigned to this complaint of 'main coil prematurely detached/separated during use' and 'device difficulty engaging target vessel' since there was a deviation from the supplied dfu that resulted in a different medical product response than intended by the manufacturer or expected by the user.

• Brand Name: TARGET XL 360 SOFT 2MM X 6CM
• 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: 17373477
• Report Number: 3008881809-2023-00370
• Device Sequence Number: 15218992
• Product Code: HCG
• UDI-Device Identifier: 07613327128260
• UDI-Public: 07613327128260
• 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): 08/21/2023

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: 12/05/2025
• Device Model Number: M0036122060
• Device Catalogue Number: M0036122060
• Device Lot Number: 24054790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• 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: COILS (UNKNOWN).; MICROCATHETER (UNKNOWN).
• Patient Sex: Unknown