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

Model Number	105039-001
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Middle aged male with history of hypertension, and renal failure that receives dialysis.While having a left upper extremity percutaneous thrombectomy, the balloon broke on the boston scientific angiojet and the pump would not work.No known harm to patient, another device was used for the procedure.

• Brand Name: ANGIOJET AVX
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11357614
• Report Number: 11357614
• Device Sequence Number: 715216
• Product Code: DXE
• UDI-Device Identifier: 08714729889045
• UDI-Public: (01)08714729889045(17)221108(10)26569846
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/18/2021
• Report Date (Section F): 02/18/2021

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 Model Number: 105039-001
• Device Lot Number: 26569846
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2021
• Patient Sequence Number: 1
• Patient Weight: 98
• Date Report Sent to FDA: 02/18/2021