MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 8MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATIONDEVICE

Catalog Number	M0036180840
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
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, visual testing as well as functional 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.The information received indicates that intermittent flush was used.In addition, a headway 21 microcatheter which has a larger id (0.021") than recommended by the dfu was used in the procedure.Per the directions for use (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"."target xxl detachable coils are compatible with stryker neurovascular 2-tip marker microcatheters with a 0.48 mm [0.019 in] internal diameter".An assignable cause of use error will be assigned to the reported complaint as the investigation confirms that there was an act or omission that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during an endovascular coil embolization procedure, when the subject coil was advanced through a non stryker microcatheter with intermittent flush, the resistance was too strong in the shaft to be advanced.When the subject coil was retrieving from the microcatheter, it got fractured at the coil junction within the microcatheter.The procedure was completed successfully by replacing the subject device.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XXL 360 8MM X 40CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATIONDEVICE
• 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: 17872935
• Report Number: 3008881809-2023-00491
• Device Sequence Number: 5953666
• Product Code: HCG
• UDI-Device Identifier: 07613327466423
• UDI-Public: 07613327466423
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161429
• 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): 10/04/2023

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: 10/24/2025
• Device Catalogue Number: M0036180840
• Device Lot Number: 23979347
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• 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: HEADWAY 21 MICROCATHETER (NON STRYKER)
• Patient Sex: Unknown