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

Model Number 106553-001

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 11/16/2021

Event Type  malfunction  

Event Description

The hub was handed off to the nurse who placed it into the angiojet, the wire was primed under saline.When priming with the saline an error message said "check saline pressure", it would not suction when stepped on the pedal.It was later noticed that the hub looked cracked and was leaking inside the machine.

• 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: 13522876
• MDR Text Key: 285543148
• Report Number: 13522876
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2021,12/16/2021

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: Other
• Device Model Number: 106553-001
• Device Catalogue Number: 106553
• Device Lot Number: 26438733
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1