MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 2MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036122030
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that the subject coil was attempted to insert and was manipulated a few times in order to place, but it prematurely detached inside the other company micro catheter.Detachment system was not used to detach the subject coil.Patient anatomy was noted to be very tortuous.The subject coil was removed along with the micro catheter.Thereafter, the micro catheter was re-inserted and procedure continued using replacement coil and completed without clinical consequences to the patient.
Event or Problem Description
It was reported that the subject coil was attempted to insert and was manipulated a few times in order to place, but it prematurely detached inside the other company micro catheter.Detachment system was not used to detach the subject coil.Patient anatomy was noted to be very tortuous.The subject coil was removed along with the micro catheter.Thereafter, the micro catheter was re-inserted and procedure continued using replacement coil and completed without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system, there are controls in the manufacturing process to ensure the product met specifications upon release.On initial inspection, the device was returned.There was no packaging returned with the device.On visual/microscopic inspection, the delivery wire was kinked at numerous locations along its length.The main coil was prematurely detached from the delivery wire.There were 5 non-stryker catheters returned with the coils.Functional test could not be performed as the coil was detached.A patency test was performed on all of the returned catheters and some passed a 0.021¿ mandrel where some passed a 0.027¿ mandrel, indicating that the catheters were not compatible (too large internal diameter (id)) one 0.027¿ catheter contained the detached coil, there was kinking and stretching noted to the detached coil.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.There was no continuous flush maintained and the non-stryker catheters used were not compatible with these coils, the internal diameter (id) was too large which would have caused the coils to double over inside the catheter lumen causing the reported premature detachment.As 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.¿ also, as per the complaint details it was mentioned that a non-stryker micro catheter was used which could have also contributed to the reported event.As per the dfu the safety and performance characteristics of the target detachable coil system (target detachable coils, inzone detachment systems, delivery systems and accessories) have not been demonstrated with other manufacturer¿s devices (whether coils, coil delivery devices, coil detachment systems, catheters, guidewires, and/or other accessories).Due to the potential incompatibility of non-stryker neurovascular devices with the target detachable coil system, the use of other manufacturer¿s device(s) with the target detachable coil system is not recommended.Based on the investigation results and available information an assignable cause of user error will be assigned to the as reported/ as analyzed main coil prematurely detached/separated during use and as analyzed coil delivery wire kinked/bent, main coil kinked/bent and main coil stretched.Issue 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.

• Brand Name: TARGET XL 360 SOFT 2MM X 3CM
• 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: 11122080
• Report Number: 3008881809-2021-00008
• Device Sequence Number: 10974203
• Product Code: HCG
• UDI-Device Identifier: 07613327128321
• UDI-Public: 07613327128321
• 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): 03/16/2021

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: 08/16/2023
• Device Model Number: M0036122030
• Device Catalogue Number: M0036122030
• Device Lot Number: 22389606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 03/16/2021
• 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: MICRO CATHETER (UNKNOWN)