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

Model Number	6531
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.A 12mm x 3.00mm nc quantum apex balloon catheter was selected for treatment to a 70% stenosed target lesion was located in the moderately tortuous and mildly calcified in left anterior descending artery.The nc quantum apex balloon catheter was advanced for dilation.The device failed to inflate.Blood was noticed within the balloon catheter.No patient harm resulted in relation to this event.
Additional Manufacturer Narrative
Initial reporter address - (b)(6).
Event or Problem Description
It was reported that a balloon rupture occurred.A 12mm x 3.00mm nc quantum apex balloon catheter was selected for treatment to a 70% stenosed target lesion was located in the moderately tortuous and mildly calcified in left anterior descending artery.The nc quantum apex balloon catheter was advanced for dilation.The device failed to inflate.Blood was noticed within the balloon catheter.No patient harm resulted in relation to this event.
Additional Manufacturer Narrative
E1: initial reporter address -(b)(6) device evaluated by manufacturer: returned product consisted of an nc quantum apex balloon catheter.The device was visually and microscopically examined.There was contrast and blood in the hub, inflation lumen, guidewire lumen, and the balloon.There was blood in the guidewire lumen and the balloon was tightly folded.The rapid port exchange was torn distally for a length of 5mm.The distance of the tear is outside the bond of the inflation lumen and guidewire lumen which indicates the device would leak upon inflation.Product analysis confirmed the reported burst, and failure to inflate, as there was a tear in the rapid port exchange which extended through both lumens and would cause a leak upon device inflation and would prevent the device from reaching and maintaining rated burst pressure.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15158701
• Report Number: 2124215-2022-28875
• Device Sequence Number: 5145919
• Product Code: LOX
• UDI-Device Identifier: 08714729783268
• UDI-Public: 08714729783268
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 09/30/2022

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: 02/07/2025
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0028827924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2022
• 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
• Patient Sex: Unknown