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

Model Number	7585
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a severely tortuous and severely calcified left anterior descending artery.A 3.50mm x 15mm maverick balloon catheter was advanced for dilation.However, during the third inflation at 6 atmospheres (atm), the balloon ruptured.The device was removed, and the procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a severely tortuous and severely calcified left anterior descending artery.A 3.50mm x 15mm maverick balloon catheter was advanced for dilation.However, during the third inflation at 6 atmospheres (atm), the balloon ruptured.The device was removed, and the procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a maverick 2mr balloon catheter.The device was visually and microscopically examined.There was blood and contrast in the inflation lumen and blood in the guidewire lumen.The balloon was loosely folded.At 7mm proximally from the tip, there were two longitudinal tears 7mm in length running parallel to each other.Product analysis confirmed the reported event, as the balloon was found to have two longitudinal tears.

• 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15710064
• Report Number: 2124215-2022-44363
• Device Sequence Number: 6630191
• Product Code: LOX
• UDI-Device Identifier: 08714729370123
• UDI-Public: 08714729370123
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 01/14/2023

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: 03/07/2024
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0026927097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 01/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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: 81 YR
• Patient Sex: Male