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

Model Number 7015

Device Problem Material Rupture (1546)

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

Event Date 11/29/2020

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 95% stenosed, 21mm x 3.0mm target lesion was located in the severely calcified left coronary artery.A 3.0mm x 15mm quantum maverick balloon catheter was advanced for dilatation but the balloon burst.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.

Event Description

It was reported that balloon rupture occurred.The 95% stenosed, 21mm x 3.0mm target lesion was located in the severely calcified left coronary artery.A 3.0mm x 15mm quantum maverick balloon catheter was advanced for dilatation but the balloon burst.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.It was further reported that the balloon was inflated once and ruptured at 15 atmospheres for 20 seconds.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and 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.There were no issues detected.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that balloon rupture occurred.The 95% stenosed, 21mm x 3.0mm target lesion was located in the severely calcified left coronary artery.A 3.0mm x 15mm quantum maverick balloon catheter was advanced for dilatation but the balloon burst.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.It was further reported that the balloon was inflated once and ruptured at 15 atmospheres for 20 seconds.

• Brand Name: QUANTUM 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: 11013767
• MDR Text Key: 221762525
• Report Number: 2134265-2020-17860
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392781
• UDI-Public: 08714729392781
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2022
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0024753326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 63