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

Model Number	7580
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.A maverick 2 mr, 2.00mm x 12mm was selected for treatment.During preparation as the balloon protector was being removed, it was observed that the catheter was broken.The procedure was completed with another same device.No patient complications were reported.
Event or Problem Description
It was reported that a shaft break occurred.A maverick 2 mr, 2.00mm x 12mm was selected for treatment.During preparation as the balloon protector was being removed, it was observed that the catheter was broken.The procedure was completed with another same device.No patient complications were reported.It was further reported that the patient was fine post procedure.

• Brand Name: 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: 12703882
• Report Number: 2134265-2021-13498
• Device Sequence Number: 12303595
• Product Code: LOX
• UDI-Device Identifier: 08714729369967
• UDI-Public: 08714729369967
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: 03/28/2024
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0027051107
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 10/31/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 11/02/2021
• Patient Sequence Number: 1