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

Model Number 45026

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)

Event Date 04/20/2023

Event Type  Death  

Event Description

It was reported that a patient died.In 2022, the patient was referred for percutaneous coronary intervention twice for chronic kidney diseases.Two to three days ago, before the procedure, the patient was receiving dialysis treatment.The target lesion was located in the left brachiocephalic vein.An angioget avx catheter was selected for arteriovenous fistula thrombectomy and uses 10ml of tissue plasminogen activator (tpa) with ns 250ml for medication.The device was run for 300 seconds of thrombectomy; operator stopped using the device due to poor condition of the patient and blood pressure was low.After the procedure was completed, and few minutes later of recovery, the patient was moved to er and eventually died due to cardiac arrest.

Event Description

It was reported that the patient died due to cardiac arrest.In 2022, the patient was referred for percutaneous coronary intervention two times, for chronic kidney disease.Two to three days before the procedure, the patient received dialysis treatment.The target lesion was located in the left brachiocephalic vein.An angioget avx catheter was selected for an arteriovenous fistula thrombectomy and 10ml of tissue plasminogen activator (tpa) with 250ml of normal saline, was used in the procedure.Thrombectomy was performed for 300 seconds, when use of the device was stopped, due to poor condition of the patient and low blood pressure.After the procedure was completed, the patient was moved to the emergency room and later died due to cardiac arrest.

• Brand Name: AVX THROMBECTOMY SET
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16950050
• MDR Text Key: 315424342
• Report Number: 2124215-2023-23884
• 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,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 45026
• Device Catalogue Number: 45026
• Device Lot Number: 0030934867
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 05/18/2023
• Supplement Dates FDA Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2022
• 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
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Sex: Male