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

Model Number	6530
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.After a 6f non-bsc guide catheter and a non-bsc guidewire crossed the lesion, predilatation was performed with a 2.50x15 maverick balloon catheter and a non-bsc stent was advanced and deployed into the lesion.A 8mm x 4.00mm nc quantum apex balloon catheter was advanced for proximal stent post-dilatation.However, the balloon did not cross the proximal edge of stent even after multiple attempts and the shaft of the balloon got broken.The device was removed from the patient intact and the procedure was completed with a 4.00 x 08 non-bsc balloon catheter.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Updated b5: describe event or problem.(e1) initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.After a 6f non-bsc guide catheter and a non-bsc guidewire crossed the lesion, predilatation was performed with a 2.50x15 maverick balloon catheter and a non-bsc stent was advanced and deployed into the lesion.A 8mm x 4.00mm nc quantum apex balloon catheter was advanced for proximal stent post-dilatation.However, the balloon did not cross the proximal edge of stent even after multiple attempts and the shaft of the balloon got broken.The device was removed from the patient intact and the procedure was completed with a 4.00 x 08 non-bsc balloon catheter.There were no patient complications nor injuries reported.It was further reported that the shaft broke 42 centimeters from the hub and the balloon was removed by pulling the remaining shaft.
Additional Manufacturer Narrative
(e1) initial reporter address 1: (b)(6).Device evaluated by mfr: returned product consisted of an nc quantum apex balloon catheter.The device was visually and microscopically examined.There was a separation of the hypotube 40.9cm from the strain relief.The separated ends of the hypotube were ovaled in shape indicating the device was kinked prior to separation.There were numerous kinks to the hypotube of the device.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was loosely folded and had blood and contrast present.The tip of the device was damaged.Product analysis confirmed the reported break as there was separation to the device.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 8mm x 4.00mm nc quantum apex balloon catheter was advanced for dilation.However, during procedure, it was noted that the balloon could not cross the lesion and found that the shaft got broken.The device was removed and the procedure was completed with a non-bsc device.There were no patient complications nor injuries reported.It was further reported that the shaft broke 42 centimeters from the hub and the balloon was removed by pulling the remaining shaft.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13453090
• Report Number: 2134265-2022-01028
• Device Sequence Number: 20002471
• Product Code: LOX
• UDI-Device Identifier: 08714729783190
• UDI-Public: 08714729783190
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2022

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: 11/06/2022
• Device Model Number: 6530
• Device Catalogue Number: 6530
• Device Lot Number: 0024725795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 02/07/2022; 03/28/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 02/17/2022; 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER (6F JR); GUIDE CATHETER (6F JR); GUIDE CATHETER (6F JR); GUIDEWIRE (BMW); GUIDEWIRE (BMW); GUIDEWIRE (BMW)
• Patient Sex: Unknown