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

Model Number	6532
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon burst occurred.A 15mm x 3.50mm nc quantum apex balloon was advanced to the target lesion, and after inflation the balloon burst.The procedure was completed with another of the same device.No patient complications resulted in relation to this event and the patient condition after the procedure was good.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc quantum apex balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast and blood in the inflation lumen and balloon.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole at the proximal marker band.There was no marker band damage detected.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported balloon ruptured.
Event or Problem Description
It was reported that a balloon burst occurred.A 15mm x 3.50mm nc quantum apex balloon was advanced to the target lesion, and after inflation the balloon burst.The procedure was completed with another of the same device.No patient complications resulted in relation to this event and the patient condition after the procedure was good.

• 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
• MDR Report Key: 9880147
• Report Number: 2134265-2020-03471
• Device Sequence Number: 3419114
• Product Code: LOX
• UDI-Device Identifier: 08714729783398
• UDI-Public: 08714729783398
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2022
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0024713081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1