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	05/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the radial artery.The 90% stenosed, 32mmx3mm, de novo target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.After crossing the lesion with a non-bsc guide wire, a 15mm x 3.00mm nc quantum apex balloon catheter was advanced for pre-dilatation.However, during inflation at 16 atmospheres, the balloon ruptured.The device was removed and pre-dilatation was performed with a 3.00x12mm nc quantum apex balloon catheter.A 3.00x32mm promus premier select stent stent was deployed and the procedure was completed.No patient complications were reported.The patient was stable and responding well to medicines.
Additional Manufacturer Narrative
Updated b5: describe event or problem.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the radial artery.The 90% stenosed, 32mmx3mm, de novo target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.After crossing the lesion with a non-bsc guide wire, a 15mm x 3.00mm nc quantum apex balloon catheter was advanced for pre-dilatation.However, during inflation at 16 atmospheres, the balloon ruptured.The device was removed and pre-dilatation was performed with a 3.00x12mm nc quantum apex balloon catheter.A 3.00x32mm promus premier select stent stent was deployed and the procedure was completed.No patient complicatons were reported.The patient was stable and responding well to medicines.It was further reported that the balloon ruptured during the second inflation.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a nc quantum apex catheter.The device was bloody, and the balloon was loosely folded.Analysis of the tip, balloon, inner/outer shaft and hypotube included microscopic and visual inspection.Inspection revealed numerous kinks in the hypotube, and a pinhole in the balloon material located 7mm from the tip of the device.Inspection of the rest of the device found no other damage or defects.The reported information indicates the device was inflated to 16atm; therefore, there is no indication the device was inflated over rbp.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the radial artery.The 90% stenosed, 32mmx3mm, de novo target lesion was located in the mildly tortuous and mildly calcifie left anterior descending artery.After crossing the lesion with a non-bsc guide wire, a 15mm x 3.00mm nc quantum apex balloon catheter was advanced for pre-dilatation.However, during inflation at 16 atmospheres, the balloon ruptured.The device was removed and pre-dilatation was performed with a 3.00x12mm nc quantum apex balloon catheter.A 3.00x32mm promus premier select stent stent was deployed and the procedure was completed.No patient complicatons were reported.The patient was stable and responding well to medicines.It was further reported that the balloon ruptured during the second inflation.

• 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: 10088524
• Report Number: 2134265-2020-06996
• Device Sequence Number: 2561230
• Product Code: LOX
• UDI-Device Identifier: 08714729783374
• UDI-Public: 08714729783374
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 08/04/2020

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: 03/18/2022
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0023504740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 05/27/2020; 07/28/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 06/22/2020; 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: RUNTHROUGH; GUIDE WIRE: RUNTHROUGH; GUIDE WIRE: RUNTHROUGH; GUIDE WIRE: RUNTHROUGH
• Patient Age: 52 YR