MAUDE Adverse Event Report: STRYKER CORPORATION AXS VECTA 74 INTERMEDIATE CATHETER; CATHETER, THROMBUS RETRIEVER

Model Number INC-11597-132

Device Problems Break (1069); Difficult to Remove (1528); Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/07/2023

Event Type  malfunction  

Event Description

Report per physician operator; as he was advancing the microcatheter through the vecta 74 catheter, the microcatheter would not advance, so her removed the microcatheter under imaging.Next, he attempted to remove the vecta 74 catheter under imaging but it was difficult to remove.Through imaging, he saw it was stuck on the vessel wall.Physician continued to remove the catheter and was finally successful.Upon removal, he discovered the tip was fractured and then immediately x-rayed the vessel and saw that the tip remained.Because this was a stroke patient, he decided it was more important to obtain timely perfusion to the brain and continue with the procedure instead of trying to retrieve the fractured tip.The physician has determined this device issue did not impact the overall outcome of the procedure.

• Brand Name: AXS VECTA 74 INTERMEDIATE CATHETER
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 17019295
• MDR Text Key: 316114606
• Report Number: 17019295
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/12/2023,05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: INC-11597-132
• Device Catalogue Number: INC-11597-132
• Device Lot Number: 20138-01
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2023
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Sex: Female