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

Model Number 105039-001

Device Problems Break (1069); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2021

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11357614
• MDR Text Key: 232806725
• Report Number: 11357614
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 08714729889045
• UDI-Public: (01)08714729889045(17)221108(10)26569846
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 105039-001
• Device Lot Number: 26569846
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Weight: 98