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 Patient Involvement (2645)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 15mm x 3.00mm nc quantum apex balloon catheter was selected for use.However, during preparation, it was noted that there was a hole in the balloon.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a nc quantum apex mr balloon catheter in two pieces.The balloon was tightly folded.Analysis of the tip, balloon (and markerbands), inner/outer shaft, and hypotube included microscopic and visual inspection.Inspection revealed a complete separation in the hypotube located 54.5cm from the strain relief, and numerous kinks in the hypotube.The fracture faces of the broken hypotube were pinched, as if kinked prior to being separated.Inspection of the rest of the device found no other damage or defect.The distal portion of the broken hypotube (balloon end) was attached to a stopcock (adapted) to inflate the balloon, and test for balloon leak (hole).The balloon could not be inflated as the hypotube was pinched and fluid could not flow into the device.
Event or Problem Description
It was reported that balloon rupture occurred.A 15mm x 3.00mm nc quantum apex balloon catheter was selected for use.However, during preparation, it was noted that there was a hole in the balloon.The procedure was completed with another of the 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: 9819755
• Report Number: 2134265-2020-02933
• Device Sequence Number: 13894997
• Product Code: LOX
• UDI-Device Identifier: 08714729783374
• UDI-Public: 08714729783374
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 04/03/2020

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: 01/03/2023
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0024987046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1