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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon material rupture occurred.A 15mm x 3.50mm nc quantum apex balloon was advanced to the target lesion.An attempt to inflate the balloon was made, but the balloon would not fully inflate.The device was viewed under x-ray and it was noticed that a hole in the balloon occurred, and the whole front of the balloon itself was a hole.The balloon was deflated twice and removed from the patient.After the balloon was removed, it was noticed that balloon was partially inflated.The procedure was successfully completed with another of the same device and no patient complications resulted in relation to this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the 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 in the inflation lumen and in the guidewire lumen.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 hole in the inner shaft 2mm proximal from the distal marker band.The device was functionally tested with a.014 inch guidewire.There were no issues advancing the guidewire.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported rupture.
Event or Problem Description
It was reported that a balloon material rupture occurred.A 15mm x 3.50mm nc quantum apex balloon was advanced to the target lesion.An attempt to inflate the balloon was made, but the balloon would not fully inflate.The device was viewed under x ray and it was noticed that a hole in the balloon occurred, and the whole front of the balloon itself was a hole.The balloon was deflated twice and removed from the patient.After the balloon was removed, it was noticed that balloon was partially inflated.The procedure was successfully completed with another of the same device and no patient complications resulted in relation to this event.

• 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: 10884807
• Report Number: 2134265-2020-15805
• Device Sequence Number: 3005938
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2023
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0025895412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1