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

Model Number	45026
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the product return contained an angiojet avx.The assembly, supply line, shaft, tip, and spike line were all visually examined for potential damage.Inspection of the shaft revealed severe damage and stretching starting 1cm from the tip, and going down until 3.5 cm from the tip.A functional test was performed.The pump was placed into the ultra drive console and the device primed with no complication.The device was run for a total time of 90 seconds in thrombectomy mode.The device stayed within the expected range of the product.No additional catheter or shaft damage was noted during testing.
Event or Problem Description
It was reported that catheter break occurred.The target lesion was located in the arm.An angiojet avx was used in a thrombectomy procedure.During withdrawal, it was noted that the catheter looked like it was about to separate between the two markers and the holes were stretched out.The procedure was completed with this device.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: 12297395
• Report Number: 2134265-2021-10126
• Device Sequence Number: 16939260
• Product Code: DXE
• UDI-Device Identifier: 08714729889045
• UDI-Public: 08714729889045
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2021

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: 05/02/2022
• Device Model Number: 45026
• Device Catalogue Number: 45026
• Device Lot Number: 0025627421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2021
• Initial Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1