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

Model Number 7015

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).

Event Description

It was reported that shaft break occurred.The 90% stenosed target lesion was located in the none calcified and non tortuous mid of left anterior descending artery.Following stent implantation, a 2.5mm x 15mm quantum maverick balloon catheter was advanced for post-dilatation.However, during expansion the physician found the front end of the catheter was broken, 40 cm from the hub but not completely fractured.The device was completely removed in a normal manner and the procedure was successfully completed with a different device.No patient complications were reported.

Event Description

It was reported that shaft break occurred.The 90% stenosed target lesion was located in the none calcified and non tortuous mid of left anterior descending artery.Following stent implantation, a 2.5mm x 15mm quantum maverick balloon catheter was advanced for post-dilatation.However, during expansion the physician found the front end of the catheter was broken, 40 cm from the hub but not completely fractured.The device was completely removed in a normal manner and the procedure was successfully completed with a different device.No patient complications were reported.

Manufacturer Narrative

E1.Initial reporter address: (b)(6).Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The device was microscopically and visually examined.There was a hypotube separation 92.8cm from the strain relief.At 90cm from the strain relief the device was kinked.There was exit notch damage to the device.There was contrast and blood in the inflation lumen and balloon folds.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported break as there was separation to the device.

• 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: 11925803
• MDR Text Key: 254329455
• Report Number: 2134265-2021-07037
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392767
• UDI-Public: 08714729392767
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2023
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0025521882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR