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

Model Number	IC068132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter (subject device) was used to access femoral artery site, when inserting the catheter (subject device) into the long sheaths, the resistance encountered as the catheter (subject device) passed area at end of their long sheaths and the catheter shaft was noticed to be fractured.The physician was able to grab the fractured part but it started to unwind while taking it out from the patient.The physician ended up access vessel via carotid and utilized other catheters and completed the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that the catheter (subject device) was used to access femoral artery site, when inserting the catheter (subject device) into the long sheaths, the resistance encountered as the catheter (subject device) passed area at end of their long sheaths and the catheter shaft was noticed to be fractured.The physician was able to grab the fractured part but it started to unwind while taking it out from the patient.The physician ended up access vessel via carotid and utilized other catheters and completed the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D4 lot # corrected ¿ from unknown to 22064615.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the catheter was seen to be kinked bent at 3-4 cm from hub.It was also kinked bent at various location along the shaft and the catheter was seen to be broken/fractured.Functional inspection was not carried out due to damage noted of returned device.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.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.This confirms the as reported event.The as reported as well as the as analyzed listed in the grid below can be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.

• Brand Name: AXS CATALYST 7 .068IN ID X 132CM - US
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11972277
• Report Number: 3008881809-2021-00243
• Device Sequence Number: 17147627
• Product Code: NRY
• UDI-Device Identifier: 07613327417227
• UDI-Public: 07613327417227
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K183464
• 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): 08/19/2021

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: 01/14/2022
• Device Model Number: IC068132
• Device Catalogue Number: IC068132
• Device Lot Number: 22064615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 08/19/2021
• 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: 6FR SHUTTLE LONG SHEATH (UNKNOWN MANUFACTURER); 7FR SHUTTLE LONG SHEATH (UNKNOWN MANUFACTURER); 6FR SHUTTLE LONG SHEATH (UNKNOWN MANUFACTURER); 7FR SHUTTLE LONG SHEATH (UNKNOWN MANUFACTURER)