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

Model Number 7010

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

Returned product consisted of a quantum maverick balloon catheter.There was blood in the balloon.There were numerous hypotube kinks.The shaft was buckled throughout the distal shaft.Functional testing was performed by applying pressure with a water filled inflation device and found that water was leaking at the most proximal buckled location.Microscopic examination of the shaft revealed a hole in the outer shaft near the distal end of the core wire which indicates at some point the shaft buckled causing the core wire to puncture through the outer shaft.

Event Description

Reportable based on device analysis completed on 10jan2020.It was reported that a kink occurred.The 99% stenosed, 16mmx2.75mm target lesion was located in the severely tortuous and calcified left main coronary artery.A 2.75mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, the balloon delivery shaft was kinked.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed a hole in the outer shaft.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9643414
• MDR Text Key: 178640461
• Report Number: 2134265-2020-00689
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392668
• UDI-Public: 08714729392668
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2022
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0023744696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 65