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

Model Number	6531
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 12mm x 2.00mm nc quantum apex balloon catheter was advanced for treatment.However, the balloon burst over the lesion.The device was removed and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc quantum apex balloon catheter.The device was microscopically and visually examined.At 3.5cm from the strain relief the hypotube was kinked.There was contrast and blood in the inflation lumen.There was blood in the guidewire lumen.There was contrast in the loosely folded balloon.The device had tip damage.The device was soaked in a water bath to break up contrast in the balloon and prepped with an inflation device filled with water and connected to the inflation port to inflate the device.At 6mm from the tip of the device there was a pinhole in the balloon.The device failed to inflate to rated burst pressure (rbp).
Event or Problem Description
It was reported that balloon rupture occurred.A 12mm x 2.00mm nc quantum apex balloon catheter was advanced for treatment.However, the balloon burst over the lesion.The device was removed and 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: 11424089
• Report Number: 2134265-2021-02345
• Device Sequence Number: 16861469
• Product Code: LOX
• UDI-Device Identifier: 08714729783220
• UDI-Public: 08714729783220
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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: 06/30/2022
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0024037107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR