MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 16MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036101650
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The coil (subject device) was returned for analysis and the device investigation revealed that the coil (subject device) had detached prematurely during use.The physician replaced the subject coil with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the main coil delivery wire was seen to be kinked/bent.The main coil was seen to be kinked/bent.The main coil was seen to be stretched.The main coil was seen to be separated from the delivery wire.Functional inspection was unable to be performed due to damage.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 was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that the subject coil got stuck in the microcatheter due to resistance at the distal end.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 severe, the delivery wire and introducer sheath were taken out together from the dispenser hoop, the tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter, the rhv was adequately tightened while the introducer sheath was in the hub (not over/under-tightened) and was opened enough to allow passage of the device through without damage, no torque was given where advancing the delivery wire, and the coil was advanced slowly and gently without applying excessive force.The main coil was returned detached/separated from the coil delivery wire.Upon visual inspection, the main coil was noted to be kinked/bent and stretched.The coil delivery wire was also noted to be kinked/bent.Although functional testing could not be performed, the damage noted to the delivery wire and the main coil were indicative of the reported friction.Based on the information provided in the complaint, it is probable that lack of continuous flush during the procedure may have contributed to the reported friction when advancing the subject coil in the microcatheter and resulted in the subsequent damage to the device.Per the device 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 guide catheter or long sheath, b) the 2-tip microcatheter and guide catheter or long sheath, and c) the 2-tip microcatheter and guidewire and delivery wire.Continuous flush also reduces the potential for thrombus formation on, and crystallization of infuscate around, the detachment zone of the target detachable coil".An assignable cause of use error will be assigned to the as reported event of 'coil in catheter friction' as well as the as analyzed events of 'coil delivery wire kinked/bent', 'main coil kinked/bent', 'main coil stretched' and 'main coil prematurely detached/separated during use' 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 STANDARD 16MM X 50CM
• 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: 19047188
• Report Number: 3008881809-2024-00148
• Device Sequence Number: 8549151
• Product Code: HCG
• UDI-Device Identifier: 04546540711304
• UDI-Public: 04546540711304
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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: 07/29/2026
• Device Catalogue Number: M0036101650
• Device Lot Number: 24444582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• 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: MICROCATHETER (UNKNOWN); TARGET COIL (STRYKER)
• Patient Sex: Unknown