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

Model Number	45026
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a loss of aspiration occurred.Two angiojet avx catheters were selected for treatment.However, after connecting the device to the angiojet thrombectomy machine, each angiojet avx catheter malfunctioned and did not properly aspirate.No known patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an angiojet avx catheter.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually examined for damage or any irregularities.The catheter shaft showed a kink located 36.5cm from the tip.Functional testing was competed per device preparation.The pump was inserted into the ultra drive unit console.The pump and device primed as designed.The device was run for a period of 120 seconds in the thrombectomy mode.The devices pressure was within the normal range.No failures or error codes were noticed during the testing.No leaks were noticed during testing.The angiojet device is iso-volumetric which means it infuses fluid and aspirates fluid at the same rate.Aspiration testing was performed by filling a 100cc beaker with water.The devices tip was submerged in the fluid and run for a period of 1 minute.The water level at the end of testing was 98cc which shows the device was aspirating as designed.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.
Event or Problem Description
It was reported that a loss of aspiration occurred.Two angiojet avx catheters were selected for treatment.However, after connecting the device to the angiojet thrombectomy machine, each angiojet avx catheter malfunctioned and did not properly aspirate.No known 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: 11966650
• Report Number: 2134265-2021-07156
• Device Sequence Number: 11556500
• Product Code: DXE
• UDI-Device Identifier: 08714729889045
• UDI-Public: 08714729889045
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 07/12/2021

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: 03/05/2023
• Device Model Number: 45026
• Device Catalogue Number: 45026
• Device Lot Number: 0027235758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1