MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET® SPIROFLEX®; CATHETER, CORONARY, ATHERECTOMY

Lot Number 27921817

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/28/2022

Event Type  malfunction  

Event Description

While attempting thrombectomy due to lysis with cath directed tpa with spiroflex catheter, catheter fractured.Attempted fragment removal with snare.Unable to completely remove spiroflex catheter.Hemostasis to groin puncture site obtained with manual pressure.Sterile dressing applied.Vascular surgery to ir and plan for or procedure.Patient family aware, patient vital signs stable.Catheter sequestered.Patient to operating room.

• Brand Name: ANGIOJET® SPIROFLEX®
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 14521835
• MDR Text Key: 292800947
• Report Number: 14521835
• Device Sequence Number: 1
• Product Code: MCX
• 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: 05/13/2022

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 Lot Number: 27921817
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2022
• Date Report to Manufacturer: 05/27/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1