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	12/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of the aware date since event date was not provided.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the anterior descending artery.A 20mm x 3.75mm nc quantum apex balloon catheter was advanced for dilation.However, during the inflation at 16 atmospheres, the balloon ruptured.The procedure was completed with no patient complications reported.
Additional Manufacturer Narrative
B3 - date of event corrected from 12/01/2021 to (b)(6) 2022.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the anterior descending artery.A 20mm x 3.75mm nc quantum apex balloon catheter was advanced for dilation.However, during the inflation at 16 atmospheres, the balloon ruptured.The procedure was completed with no patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the anterior descending artery.A 20mm x 3.75mm nc quantum apex balloon catheter was advanced for dilation.However, during the inflation at 16 atmospheres, the balloon ruptured.The procedure was completed with 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 in the inflation lumen.At 10.6cm from the tip of the device, the guidewire lumen was punctured exposing the inflation lumen which would cause device leakage.The damage indicates an interaction with a guidewire.The balloon was loosely folded, and the tip of the device was damaged.

• 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: 13143810
• Report Number: 2134265-2021-16394
• Device Sequence Number: 4650916
• Product Code: LOX
• UDI-Device Identifier: 08714729783510
• UDI-Public: 08714729783510
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2022

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: 12/18/2023
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0026540217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 01/04/2022; 03/01/2022
• Initial Report FDA Received Date: 01/03/2022
• Supplement Report FDA Received Date: 01/14/2022; 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2020
• 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