MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Lot Number 28133044

Device Problems Material Rupture (1546); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 01/31/2022

Event Type  malfunction  

Event Description

During cardiac catheterization revascularization procedure, there was rupture of balloon in the stented segment post dilation.This caused the balloon to entrap within the stented segment.The distal tip of the balloon disengaged from the shaft.Initial capture of the distal tip of the balloon was accomplished with a snare and pulled into the guide but then it became embolized into the lad (left anterior descending artery).There were multiple wires placed into the lad to try to pull the balloon tip back into the guide, ultimately a 4mm snare was able to trap the distal tip and the entire system was removed.The balloon tip was visualized outside the body.The procedure was successfully completed.

• Brand Name: NC QUANTUM APEX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 13541261
• MDR Text Key: 285673670
• Report Number: 13541261
• Device Sequence Number: 1
• Product Code: LOX
• 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: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 28133044
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2022
• Date Report to Manufacturer: 02/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Sex: Male
• Patient Weight: 37 KG
• Patient Race: White