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

Model Number 6531

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem Embolism/Embolus (4438)

Event Date 01/31/2022

Event Type  Injury  

Event Description

It was reported via facility medwatch # (b)(4) that a balloon rupture and tip detachment occurred.During cardiac catherization revascularization procedure, a 12mm x 3.50mm nc quantum apex balloon catheter was being advanced for post dilation.However, there was rupture of balloon in the stented post dilation which 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 left anterior descending artery (lad).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 and the procedure was successfully completed.

• Brand Name: NC QUANTUM APEX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13653885
• MDR Text Key: 286644628
• Report Number: 2134265-2022-02315
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729783282
• UDI-Public: 08714729783282
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0028133044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 37 KG
• Patient Race: White