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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The fibrotic and diffusely diseased target lesion was located in the moderately tortuous and mildly calcified proximal to distal left anterior descending (lad) artery.The physician cannulated a guide catheter at the left main ostium and crossed the lesion with a guidewire.A 12mm x 3.00mm nc quantum apex balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
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 were numerous kinks to the hypotube of the device.There was contrast and blood in the inflation lumen and the balloon.There was blood in the guidewire lumen and the balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.At 17mm from the tip of the device there was a pinhole in the balloon.The device failed to inflate to rbp.Product analysis confirmed the reported burst, as there was a pinhole in the balloon.
Event or Problem Description
It was reported that balloon rupture occurred.The fibrotic and diffusely diseased target lesion was located in the moderately tortuous and mildly calcified proximal to distal left anterior descending (lad) artery.The physician cannulated a guide catheter at the left main ostium and crossed the lesion with a guidewire.A 12mm x 3.00mm nc quantum apex balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.

• 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: 13252959
• Report Number: 2134265-2022-00212
• Device Sequence Number: 4269935
• Product Code: LOX
• UDI-Device Identifier: 08714729783268
• UDI-Public: 08714729783268
• 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): 04/05/2022

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: 10/11/2024
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0028184442
• 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: 01/03/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2021
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 63 KG