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

Model Number	7590
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified distal right coronary artery.A 1.50mm x 20mm maverick balloon catheter was advanced for dilatation.However, during inflation, the balloon did not expand and was noted to be ruptured.Another 1.50mm x 20mm maverick balloon catheter was advanced, but also ruptured.The procedure was completed with a different device.There were no patient complications 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 microscopically and visually examined.The device was returned with the product mandrel but was not returned in the device.There was both contrast and blood in the inflation lumen, guidewire lumen, and balloon.The balloon was loosely folded and had tip damage to the device.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole in the balloon located 14mm from the tip of the device.There was no markerband damage detected as the pinhole was near the markerband.The device failed to inflate to the rated burst pressure.Product analysis confirmed the reported event, as during functional testing the device was found to have a pinhole damage to the balloon.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified distal right coronary artery.A 1.50mm x 20mm maverick balloon catheter was advanced for dilatation.However, during inflation, the balloon did not expand and was noted to be ruptured.Another 1.50mm x 20mm maverick balloon catheter was advanced, but also ruptured.The procedure was completed with a different device.There were no patient complications reported and the patient status was stable.

• 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: 11781670
• Report Number: 2134265-2021-05823
• Device Sequence Number: 3722065
• 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): 06/09/2021

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: 04/28/2023
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0025475686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR