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

Model Number	7015
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary heart disease and underwent percutaneous coronary intervention.The target lesion was located in right coronary artery.A 2.5mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, during the procedure, the balloon was fractured.The device was removed, and the procedure was completed with another of the same device.No patient complications were reported, and the patient status was stable.
Additional Manufacturer Narrative
E1: initial reporter updated.
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary heart disease and underwent percutaneous coronary intervention.The target lesion was located in right coronary artery.A 2.5mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, during the procedure, the balloon was fractured.The device was removed, and the procedure was completed with another of the same device.No patient complications were reported, and the patient status was stable.It was further reported that the shaft was not broken as what was previously reported, rather it was the balloon material that ruptured.There was a discontinuous calcification in the proximal end of left anterior descending artery having a severely stenosis of 85%.Also, a calcified nodule was noted in the proximal end of circumflex branch which was 80% severely stenosed.In addition, the balloon ruptured on the fourth inflation at 18 atmospheres for 1 second.

• Brand Name: QUANTUM MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16709565
• Report Number: 2124215-2023-16659
• Device Sequence Number: 20673221
• Product Code: LOX
• UDI-Device Identifier: 08714729392767
• UDI-Public: 08714729392767
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• 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): 04/18/2023

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: 12/17/2023
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0026533686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 75 KG