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

Model Number 7015

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2020

Event Type  malfunction  

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 a complete separation at 86. 9cm distal of the strain relief. There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen. The balloon was loosely folded. Microscopic inspection revealed tip damage. The device was soaked in a water bath for two days to loosen the blood and contrast in the device. The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device. No issues were detected. Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on device analysis completed on 16-may-2020. It was reported that balloon leak occurred. The target lesion was located in a coronary artery. A 2. 75mm x 15mm quantum maverick balloon catheter was selected for use, but after unpacking, a leaking gas was noted and could not be inflated. The procedure was completed with another of the same device. There were no patient complications reported and the patient was stable. However, returned device analysis revealed a separated 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: 10134256
• MDR Text Key: 194515219
• Report Number: 2134265-2020-07013
• Device Sequence Number: 1
• Product Code: LOX
• 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,distri

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/09/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0023915848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial