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

Model Number	6534
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	11/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event - used the first date of the month of the aware date, as no event date is provided.
Event or Problem Description
It was reported that balloon rupture occurred.A 30mm x 2.25mm nc quantum apex balloon catheter was advanced for dilation.However, during inflation at 18 atmospheres, the balloon broke.The procedure was completed with another of same device.There were no patient complications reported.
Additional Manufacturer Narrative
B3: date of event - used the first date of the month of the aware date, as no event date is provided.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 and blood in the inflation lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.There was a pinhole at the distal end of the distal marker band.There was no marker band damage detected.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.A 30mm x 2.25mm nc quantum apex balloon catheter was advanced for dilation.However, during inflation at 18 atmospheres, the balloon broke.The procedure was completed with another of same device.There were no patient complications reported.

• 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: 10896758
• Report Number: 2134265-2020-16253
• Device Sequence Number: 11514591
• Product Code: LOX
• UDI-Device Identifier: 08714729783565
• UDI-Public: 08714729783565
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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: 02/12/2022
• Device Model Number: 6534
• Device Catalogue Number: 6534
• Device Lot Number: 0023339179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1