MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 7 .068IN ID X 132CM - US; CATHETER, PERCUTANEOUS

Model Number	IC068132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available to the manufacturer.
Event or Problem Description
It was reported that during procedure, while retrieving a clot from the patient's anatomy, the subject catheter shaft was noted broken at the proximal end by the hub.The clot was retrieved after one pass and the procedure was completed successfully.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
D4 lot#/serial# - updated d4 expiration date - added d10/h3 product available to stryker - updated h3 device evaluated by mfg - updated h3 summary attached - updated h4 manufacturing date ¿ added the subject device was returned and the lot numbers was confirmed from the hub of the devices.Visual analysis revealed that the catheter shaft was broken at 68 mm from the proximal end of the hub.Functional analysis was not performed based on the damage noted during analysis.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.Additional information indicated that there were no anomalies noted to the device prior to use and the device was prepared as per the dfu.It is probable that the device was damaged during the clinical procedure.An assignable cause of procedural factors will be assigned to the reported event, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu, but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during procedure, while retrieving a clot from the patient's anatomy, the subject catheter shaft was noted broken at the proximal end by the hub.The clot was retrieved after one pass and the procedure was completed successfully.There were no reported clinical consequences to the patient.

• Brand Name: AXS CATALYST 7 .068IN ID X 132CM - US
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9760147
• Report Number: 3008881809-2020-00053
• Device Sequence Number: 687656
• Product Code: DQY
• UDI-Device Identifier: 07613327417227
• UDI-Public: 07613327417227
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K183463
• 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): 04/28/2020

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: 08/19/2021
• Device Model Number: IC068132
• Device Catalogue Number: IC068132
• Device Lot Number: 21686621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 04/28/2020
• 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: INFINITY LONG SHEATH CATHETER(STRYKER); MARKSMAN CATHETER(TELEFLEX MEDICAL); SOLITAIRE¿ X REVASCULARIZATION DEVICE(MEDTRONIC)