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

Model Number	6531
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture and tip detachment were encountered.An unknown stent was placed in the middle of an unknown vessel but was not fully expanded.A non-bsc balloon was inflated three times, however, it burst.A 12mm x 4.50mm nc quantum apex balloon catheter was then inflated, however, during the second inflation, at approximately 34 atmospheres, it also burst.It was noted that the tip with the marker, came off when the balloon burst.The marker and the fragment were removed by pulling the guide and the sheath out of the access site.No further complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
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 were numerous kinks.There was a complete separation on the shaft at 140cm distal of the strain relief.The shaft appeared to have burst.There was contrast and blood in the inflation lumen.There was no inner shaft.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture and tip detachment were encountered.An unknown stent was placed in the middle of an unknown vessel but was not fully expanded.A non-bsc balloon was inflated three times, however, it burst.A 12mm x 4.50mm nc quantum apex balloon catheter was then inflated, however, during the second inflation, at approximately 34 atmospheres, it also burst.It was noted that the tip with the marker, came off when the balloon burst.The marker and the fragment were removed by pulling the guide and the sheath out of the access site.No further complications were reported and the patient's status was stable.

• 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: 9100569
• Report Number: 2134265-2019-10792
• Device Sequence Number: 16848739
• Product Code: LOX
• UDI-Device Identifier: 08714729783312
• UDI-Public: 08714729783312
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/29/2019

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 Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0023332814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1