MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036181040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
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 device was received within a non stryker microcatheter and there was no packaging returned with the device, therefore it cannot be confirmed that the correct device was returned.On visual/microscopic inspection, the delivery wire was kinked at 18cm and 39cm from the distal end.The main coil was noted to be physically detached from the delivery wire.The main coil was extended out of the distal end of the microcatheter.The main coil was noted to be extensively stretched.The microcatheter was noted to be kinked at 17cm & 19cm from the distal end.On functional testing, the microcatheter was unable to be flushed and the coil could not be removed, there was dried blood noted to the proximal end of the microcatheter adjacent to the hub, blocking the microcatheter.The microcatheter id was confirmed to be incompatible with the target xxl (0.022¿ mandrel passes).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.As per the available information, the device was confirmed to be in good condition during preparation/prior to use on the patient.Continuous flush was not set up and maintained throughout the clinical procedure.The device was returned and the main coil was noted to be detached and stuck within the returned microcatheter due to dried blood.Dried blood is an indication of insufficient flush.The returned microcatheter was found to have an incompatible inner diameter (too large).It is probable that the lack of flush and blood within the microcatheter coupled with the incompatible microcatheter caused the reported event.An assignable cause of user error will be assigned to the reported coil in catheter friction and main coil stretched, and to the analyzed coil delivery wire kinked/bent, main coil prematurely detached/separated during use, main coil stretched and coil jammed, as the issue investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.
Event or Problem Description
Analysis of the device revealed that the main coil had prematurely detached/separated during use.There was no clinical consequence to the patient reported as a result of this event.

• Brand Name: TARGET XXL 360 10MM X 40CM
• 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: 11704636
• Report Number: 3008881809-2021-00173
• Device Sequence Number: 4331048
• Product Code: HCG
• UDI-Device Identifier: 07613327128406
• UDI-Public: 07613327128406
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2021

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: 08/26/2023
• Device Model Number: M0036181040
• Device Catalogue Number: M0036181040
• Device Lot Number: 22402987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1