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

Model Number	6530
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified obtuse marginal artery.A 8mm x 2.50mm nc quantum apex balloon catheter was advanced for post dilatation.However, during the first inflation at 12 atmospheres (atm) for 2 seconds, the balloon ruptured.Subsequently, a 12mm x 2.50mm nc quantum apex balloon catheter was advanced.However, during the first inflation at 8 atm for 2 seconds, the balloon ruptured.The device was removed intact and the procedure was completed with a non-boston scientific balloon catheter.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc quantum apex balloon catheter.The device was visually and microscopically examined.There was contrast and blood in the inflation lumen and balloon.There was blood in the guidewire lumen, and the balloon was loosely folded.At 5mm from the tip moving proximally for a length of 8mm, the balloon has a longitudinal tear.Product analysis confirmed the reported burst, as there was a longitudinal tear in the balloon.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified obtuse marginal artery.A 8mm x 2.50mm nc quantum apex balloon catheter was advanced for post dilatation.However, during the first inflation at 12 atmospheres (atm) for 2 seconds, the balloon ruptured.Subsequently, a 12mm x 2.50mm nc quantum apex balloon catheter was advanced.However, during the first inflation at 8 atm for 2 seconds, the balloon ruptured.The device was removed intact and the procedure was completed with a non-boston scientific balloon catheter.There were no patient complications 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
• 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: 14323678
• Report Number: 2134265-2022-04891
• Device Sequence Number: 11888397
• Product Code: LOX
• UDI-Device Identifier: 08714729783138
• UDI-Public: 08714729783138
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2022

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: 06/22/2024
• Device Model Number: 6530
• Device Catalogue Number: 6530
• Device Lot Number: 0027542452
• 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: 04/14/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2021
• 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: EBU 3.5; GUIDE CATHETER: EBU 3.5
• Patient Sex: Unknown
• Patient Race: Asian