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 Consequences Or Impact To Patient (2199)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2020 as the correct date was not provided.
Event or Problem Description
It was reported that balloon rupture occurred.A 15mm x 3.75mm nc quantum apex balloon catheter was selected for use.However, it was noted that the balloon ruptured at 16 atmospheres.There were no patient complications reported.
Additional Manufacturer Narrative
B3 - date of event: used (b)(6) 2020 as the correct date was not provided.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 was contrast and blood in the inflation lumen and balloon.The balloon was loosely folded.There was a pinhole 4mm distal from the proximal marker band.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported balloon rupture.
Event or Problem Description
It was reported that balloon rupture occurred.A 15mm x 3.75mm nc quantum apex balloon catheter was selected for use.However, it was noted that the balloon ruptured at 16 atmospheres.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: 10248707
• Report Number: 2134265-2020-09094
• Device Sequence Number: 596802
• Product Code: LOX
• UDI-Device Identifier: 08714729783404
• UDI-Public: 08714729783404
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 01/07/2021

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: 02/05/2023
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0025166259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1