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

Model Number 7585

Device Problem Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 85% stenosed, target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.00mm x 15mm maverick balloon catheter was advanced for dilatation.However, during inflation at nominal pressure, the balloon ruptured due to severe calcification.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a maverick 2 balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast in the inflation lumen, and blood and contrast in the balloon.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.The outer shaft was stretched down for 4mm starting 2mm distal of the exit notch prevented the balloon from inflating.There was a pinhole at the distal marker band.There was no marker band damage detected.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that balloon rupture occurred.The 85% stenosed, target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.00mm x 15mm maverick balloon catheter was advanced for dilatation.However, duirng inflation at nominal pressure, the balloon ruptured due to severe calcification.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was good.

• Brand Name: MAVERICK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11037849
• MDR Text Key: 222398306
• Report Number: 2134265-2020-18177
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729370062
• UDI-Public: 08714729370062
• Combination Product (y/n): N
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2022
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0024371777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR