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

Model Number 7580

Device Problem Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2020

Event Type  malfunction  

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.The balloon was tightly folded.The device was functionally tested with a 0.014 inch guidewire.The outer shaft was damaged 6mm proximal of the exit notch.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported difficulty advancing the guidewire.

Event Description

It was reported that a balloon device could not be placed onto a wire.During preparation and while outside the patient, a 2.00mm x 12mm maverick balloon could not be placed onto the wire.The procedure was completed with another of the same device.No patient complications were reported in relation to this event.However, the device was returned and analysis revealed outer shaft damage.

• Brand Name: 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: 10742010
• MDR Text Key: 213261018
• Report Number: 2134265-2020-14833
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729369967
• UDI-Public: 08714729369967
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2023
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0025095998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2020
• 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