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	04/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the right femoral artery.The 90% stenosed, 2.25mmx20mm, eccentric, de novo target lesion containing a >=90 degrees bend was located in the severely tortuous and severely calcified left circumflex artery.After the lesion was engaged with a 6f non-bsc guide catheter and crossed with a non-bsc guidewire, pre-dilatation was performed with a 1.50x6 non-bsc balloon catheter resulting to 80% residual stenosis.Following pre-dilatation, a 2.25x23mm non-bsc stent was deployed and a 12mm x 2.50mm nc quantum apex balloon catheter was advanced for post dilatation.However, during inflation at 8 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with a different device.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc quantum apex balloon catheter.The device was microscopically and visually examined.There was contrast and blood in the inflation lumen.There was blood in the guidewire lumen.There was contrast in the loosely folded balloon.At 3mm from the tip moving proximally for a length of 8mm the balloon has a longitudinal tear.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the right femoral artery.The 90% stenosed, 2.25mmx20mm, eccentric, de novo target lesion containing a =90 degrees bend was located in the severely tortuous and severely calcified left circumflex artery.After the lesion was engaged with a 6f non-bsc guide catheter and crossed with a non-bsc guidewire, pre-dilatation was performed with a 1.50x6 non-bsc balloon catheter resulting to 80% residual stenosis.Following pre-dilatation, a 2.25x23mm non-bsc stent was deployed and a 12mm x 2.50mm nc quantum apex balloon catheter was advanced for post dilatation.However, during inflation at 8 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with a different device.There were no patient complications reported and the patient 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
• MDR Report Key: 11838996
• Report Number: 2134265-2021-06429
• Device Sequence Number: 4635240
• Product Code: LOX
• UDI-Device Identifier: 08714729783244
• UDI-Public: 08714729783244
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: 11/03/2023
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0026292634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 70