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	04/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed, 16mm x 3.00mm, concentric, de novo target lesion with a significant bend of <=45 degrees was located in the left circumflex artery.A 15mm x 3.00mm nc quantum apex balloon catheter was advanced for pre-dilatation.However, during inflation, the balloon ruptured due to calcification.The device was removed and the procedure was completed with a different device.No patient complications nor injuries were reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluation by mfr: 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 in the inflation lumen and balloon.The balloon was loosely folded.Microscopic inspection revealed tip damage.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.No defects were 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.The 75% stenosed, 16mm x 3.00mm, concentric, de novo target lesion with a significant bend of <=45 degrees was located in the left circumflex artery.A 15mm x 3.00mm nc quantum apex balloon catheter was advanced for pre-dilatation.However, during inflation, the balloon ruptured due to calcification.The device was removed and the procedure was completed with a different device.No patient complications nor injuries were reported and the patient status was stable.It was further reported that the balloon ruptured during initial inflation at 16 atmospheres for 15 seconds.
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed, 16mm x 3.00mm, concentric, de novo target lesion with a significant bend of <=45 degrees was located in the left circumflex artery.A 15mm x 3.00mm nc quantum apex balloon catheter was advanced for pre-dilatation.However, during inflation, the balloon ruptured due to calcification.The device was removed and the procedure was completed with a different device.No patient complications nor injuries were reported and the patient status was stable.It was further reported that the balloon ruptured during initial inflation at 16 atmospheres for 15 seconds.

• 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: 10009706
• Report Number: 2134265-2020-05787
• Device Sequence Number: 2897695
• Product Code: LOX
• UDI-Device Identifier: 08714729783374
• UDI-Public: 08714729783374
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2020

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: 06/04/2022
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0023901479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 05/05/2020; 06/17/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 06/01/2020; 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 60