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

Model Number 7585

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2020

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 a complete separation at 44.9cm and 79.4cm distal of the strain relief.There was contrast and blood in the inflation lumen.The balloon was loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on device analysis completed on 07feb2021.It was reported that shaft kink occurred.The 94% stenosed, 1.5mmx15mm, target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 1.50mm x 15mm maverick balloon catheter was advanced for dilation but the delivery shaft was kinked at 60 centimeters from the hub.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient's status was stable.However, returned device analysis revealed a shaft detach.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 a complete separation at 44.9cm and 79.4cm distal of the strain relief.There was contrast and blood in the inflation lumen.The balloon was loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 11419063
• MDR Text Key: 234953438
• Report Number: 2134265-2021-02847
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729370055
• UDI-Public: 08714729370055
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2022
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0024962427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2019
• 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: 51 YR
• Patient Weight: 76