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	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned product consisted of an nc quantum apex balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous hypotube kinks.The balloon was tightly folded.There was contrast and blood in the inflation lumen, and blood in the guidewire lumen.There was an 8mm tear starting at the port weld and extending distally.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm a balloon rupture but did confirm shaft damage which would have prevent the balloon from inflating.
Event or Problem Description
It was reported that balloon rupture occurred.A 15mm x 4.50mm nc quantum apex balloon catheter was advanced for dilation.However, after insertion, the balloon ruptured without being inflated.The procedure was completed with another nc quantum apex balloon catheter.No patient complications were 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: 8613976
• Report Number: 2134265-2019-05283
• Device Sequence Number: 1684907
• Product Code: LOX
• UDI-Device Identifier: 08714729783428
• UDI-Public: 08714729783428
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2019

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: 10/26/2021
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0022853736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1