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

Model Number 45026

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2022

Event Type  malfunction  

Event Description

Reportable based on the device analysis completed on 15nov2022.It was reported that pump burst occurred.The target lesion was located in the radial anteriovenous fistula.An angiojet avx was used for the thrombectomy.However, during the procedure.The pump burst.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis revealed a hypotube break.

Manufacturer Narrative

Lot number: reported as either 29754307, 29747046, or 29747047.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 multiple bends and kinks.Functional testing was attempted; however, the device would not prime.During analysis at the severely kinked location at 38 cm from the tip the hypotube was clearly broken and completely separated.The device was x-rayed to verify the broken hypotube.The device could not be functionally tested due to the extreme damage on the device.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• Brand Name: AVX THROMBECTOMY SET
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15941770
• MDR Text Key: 305617534
• Report Number: 2124215-2022-51108
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2022

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
• Device Operator: Health Professional
• Device Model Number: 45026
• Device Catalogue Number: 45026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1