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	11/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 2.75mm x 12mm maverick 2 balloon catheter was selected for use.However, while advancing the balloon inside the guide catheter, the shaft broke.The procedure was not completed due to this event.There were no patient complications nor injuries reported and the patient status was stable.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 2.75mm x 12mm maverick 2 balloon catheter was selected for use.However, while advancing the balloon inside the guide catheter, the shaft broke.The procedure was not completed due to this event.There were no patient complications nor injuries reported and the patient status was stable.
Additional Manufacturer Narrative
A2 age at time of event: 18 years or older.Returned product consisted of a maverick 2 mr balloon catheter.The device was visually and microscopically examined.At 19cm from the strain relief the hypotube was separated.The separated ends were ovaled in shape indicating the device was kinked prior to separation.The hypotube of the device has numerous kinks.There was contrast in the inflation lumen and the balloon was tightly folded.The shipping mandrel was still in place but was able to be removed without issue or resistance.The tip of the device was damaged.

• Brand Name: MAVERICK
• 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: 13170093
• Report Number: 2134265-2022-00028
• Device Sequence Number: 1830097
• Product Code: LOX
• UDI-Device Identifier: 08714729369998
• UDI-Public: 08714729369998
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 03/09/2022

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: 11/12/2022
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0024765549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• 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: 03/07/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2019
• 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: Male