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

Model Number	6531
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 2134265-2022-02315
• Device Sequence Number: 17587426
• Product Code: LOX
• UDI-Device Identifier: 08714729783282
• UDI-Public: 08714729783282
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/03/2024
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 37 KG
• Patient Race: White