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

Model Number 6531

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2018

Event Type  malfunction  

Event Description

It was reported that balloon detachment occurred.A 12mm x 4.00mm nc quantum apex balloon catheter was selected for used to dilate the lesion; however, it was noted that the balloon ripped off.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a nc quantum apex balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the inflation lumen is separated, and the distal section of the device is missing.The missing parts are the distal inflation lumen, entire guidewire lumen, balloon, marker band, and tip.There are multiple kinks along the hypotube and on the core wire.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the distal section of the device is missing.

Event Description

It was reported that balloon detachment occurred.A 12mm x 4.00mm nc quantum apex balloon catheter was selected for used to dilate the lesion; however, it was noted that the balloon ripped off.No patient complications were reported.

• Brand Name: NC QUANTUM APEX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8182292
• MDR Text Key: 130994794
• Report Number: 2134265-2018-64513
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729783305
• UDI-Public: 08714729783305
• Combination Product (y/n): N
• PMA/PMN Number: K121667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2021
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0022788757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 01/31/2019
• Supplement Dates FDA Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1