MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 3MM X 9CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036123090
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the embolization, first coil was successfully advanced using a microcatheter.However, when advancing the second coil, resistance was noted at the hub of the microcatheter.When the coil was removed, stretch was noted and the coil was replaced with a new coil.This coil also experienced friction at the hub of the microcatheter and was stuck inside the shaft of the microcatheter.Both coil and the microcatheter were removed from the patient's anatomy.The physician replaced the microcatheter and used it to deliver the subject coil.Friction was also reported at the hub and inside the microcatheter when advancing the subject coil.During removal of the subject coil, it prematurely detached inside the microcatheter.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 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 during the procedure, the subject coil prematurely detached.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 as per the dfu, continuous flush was not set up and maintained throughout the clinical procedure.In the case of this complaint, it is most likely that the device encountered difficulties while advancing in the microcatheter due to a lack of continuous flush which resulted in premature detachment when the coil was manipulated against resistance.Per the dfu, "in order to achieve optimal performance of the target 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 target detachable coil." an assignable cause of use error will be assigned to this complaint, as the investigation confirmed that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer and/or expected by the user.
Event or Problem Description
It was reported that during the embolization, first coil was successfully advanced using a microcatheter.However, when advancing the second coil, resistance was noted at the hub of the microcatheter.When the coil was removed, stretch was noted and the coil was replaced with a new coil.This coil also experienced friction at the hub of the microcatheter and was stuck inside the shaft of the microcatheter.Both coil and the microcatheter were removed from the patient's anatomy.The physician replaced the microcatheter and used it to deliver the subject coil.Friction was also reported at the hub and inside the microcatheter when advancing the subject coil.During removal of the subject coil, it prematurely detached inside the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XL 360 SOFT 3MM X 9CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 12262858
• Report Number: 3008881809-2021-00321
• Device Sequence Number: 11456153
• Product Code: HCG
• UDI-Device Identifier: 07613327128284
• UDI-Public: 07613327128284
• 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): 10/04/2021

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: 01/05/2024
• Device Model Number: M0036123090
• Device Catalogue Number: M0036123090
• Device Lot Number: 22648158
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR 1018 MICROCATHETER (STRYKER); RENEGADE 18 MICROCATHETER (STRYKER); XXL 360 8MM X 40CM COIL ( STRYKER); XXL360 6MM X 40CM COIL (STRYKER)