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

Model Number	7590
Medical Device Problem Codes	Material Rupture (1546); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 92% stenosed target lesion was located in the severely tortuous and severely calcified mid left anterior descending artery.A 1.50mm x 20mm maverick balloon catheter was advanced but failed to cross the lesion.However, during inflation, the balloon ruptured.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 92% stenosed target lesion was located in the severely tortuous and severely calcified mid left anterior descending artery.A 1.50mm x 20mm maverick balloon catheter was advanced but failed to cross the lesion.However, during inflation, the balloon ruptured.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a maverick 2 mr balloon catheter.The device was microscopically and visually examined.There was contrast present in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.There were no irregularities or damage found to the device.The balloon catheter was prepped with an inflation device filled with water to inflate the device to the rated burst pressure.The balloon was able to be inflated and maintained pressure as well as deflated with no issues.

• 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: 12230292
• Report Number: 2134265-2021-09609
• Device Sequence Number: 3802068
• Product Code: LOX
• UDI-Device Identifier: 08714729370154
• UDI-Public: 08714729370154
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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: 01/29/2024
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0026717358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR