MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET AVX; CATHETER, EMBOLECTOMY

Model Number	45026
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a procedure was cancelled.The target lesion was located in the arm fistula.An angiojet avx catheter was used for thrombectomy procedure.During the procedure, the device could not prime and there was an error message displayed when using several attempts.The procedure was not completed due to this event.No patient complications were reported.

• Brand Name: ANGIOJET AVX
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12538303
• Report Number: 2134265-2021-11895
• Device Sequence Number: 14511036
• Product Code: DXE
• UDI-Device Identifier: 08714729889045
• UDI-Public: 08714729889045
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133629
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2021

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: 02/20/2022
• Device Model Number: 45026
• Device Catalogue Number: 45026
• Device Lot Number: 0025477374
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1