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

Model Number	7015
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient was hospitalized for acute myocardial infarction, and underwent emergency coronary artery drug-coated stent implantation.After stent implantation, poor inflation on the proximal end of the stent was observed, and the stent was prepared for stent molding.A 3.5mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, during the procedure, the balloon was slightly twisted when entering into the y valve, and the connection shaft was fractured.The broken balloon was then removed from the y valve, and the procedure was completed with a different device.There was no adverse effect on the patient.

• Brand Name: QUANTUM MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12576092
• Report Number: 2134265-2021-12218
• Device Sequence Number: 3488404
• Product Code: LOX
• UDI-Device Identifier: 08714729392804
• UDI-Public: 08714729392804
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/05/2021

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: 03/27/2023
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0025415848
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR