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

Model Number	6533
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that balloon rupture occurred.A 20mm x 3.25mm nc quantum apex balloon catheter was advanced for post dilatation.However, during inflation at 20 atmospheres, the balloon ruptured.The procedure was completed with a different device and there were no patient complications reported.
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.The returned device was visually and microscopically examined.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was loosely folded.At 14mm from the tip moving proximally for a length of 14mm, the balloon has a longitudinal tear.
Event or Problem Description
It was reported that balloon rupture occurred.A 20mm x 3.25mm nc quantum apex balloon catheter was advanced for post dilatation.However, during inflation at 20 atmospheres, the balloon ruptured.The procedure was completed with a different device and 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12519227
• Report Number: 2134265-2021-11946
• Device Sequence Number: 4460064
• Product Code: LOX
• UDI-Device Identifier: 08714729783497
• UDI-Public: 08714729783497
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

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: 11/11/2023
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0026340772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2020
• 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