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

Catalog Number	M0036181040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is report 1 of 4.The device history record confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not 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 product was not returned, however, additional information received reported by the customer indicated that intermittent flush was maintained.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.¿ 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.Based on the investigation results and available information an assignable cause of user error will be assigned to this complaint.
Event or Problem Description
It was reported that there was resistance when the coil (subject device) was advanced into the catheter.The physician was able to remove the coil and it was found broken in catheter.The coil was replaced with another and the procedure was completed successfully.There were no adverse consequences to the patient.

• 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
• MDR Report Key: 9490049
• Report Number: 3008881809-2019-00398
• Device Sequence Number: 258666
• Product Code: HCG
• UDI-Device Identifier: 07613327128406
• UDI-Public: 07613327128406
• Combination Product (Y/N): N
• 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): 12/18/2019

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: No Information
• Device Expiration Date: 01/07/2022
• Device Catalogue Number: M0036181040
• Device Lot Number: 21116390
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1