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

Model Number 3825

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 12/25/2019

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that a shaft break occurred.A percutaneous coronary intervention was being performed.Vascular access was obtained via the right radial artery.The target lesion was located in the non tortuous and non calcified, eccentric, de novo lesion in the left circumflex coronary artery.A 2.75 mm x 15.00mm agent drug-coated balloon was advanced into the guide catheter where the balloon shaft broke.The procedure was successfully completed with a different device without issue or patient injury.

Manufacturer Narrative

Device is a combination product.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the hypotube was separated 54.8cm from the hub.There were multiple kinks along the hypotube.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the hypotube was separated but appeared to have been kinked prior to separation.

Event Description

It was reported that a shaft break occurred.A percutaneous coronary intervention was being performed.Vascular access was obtained via the right radial artery.The target lesion was located in the non tortuous and non calcified, eccentric, de novo lesion in the left circumflex coronary artery.A 2.75 mm x 15.00mm agent drug-coated balloon was advanced into the guide catheter where the balloon shaft broke.The procedure was successfully completed with a different device without issue or patient injury.

• Brand Name: AGENT
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9574304
• MDR Text Key: 178014979
• Report Number: 2134265-2019-16342
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2020
• Device Model Number: 3825
• Device Catalogue Number: 3825
• Device Lot Number: 8544H18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR