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

Model Number 3825

Device Problem Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2020

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.The 100% in stent restenosed (isr) target lesion was located in the moderately tortuous and severely calcified right coronary artery (rca).Following predilitation, a 3.50 mm x 20.00 mm agent dcb balloon was advanced to dilate the target lesion, but the balloon burst.It was noted that the balloon burst due to the distal hypotube advancing through the calcified isr lesion.The procedure was completed with another of the same device.No patient complications resulted in relation to this event.

Manufacturer Narrative

The returned product consisted of an agent (dcb) balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 34.3cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was loosely folded.There was a longitudinal tear 24mm long starting 1mm from the proximal end of the balloon.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported balloon ruptured.

Event Description

It was reported that a balloon rupture occurred.The 100% in stent restenosed (isr) target lesion was located in the moderately tortuous and severely calcified right coronary artery (rca).Following predlitation, a 3.50 mm x 20.00 mm agent dcb balloon was advanced to dilate the target lesion, but the balloon burst.It was noted that the balloon burst due to the distal hypotube advancing through the calcified isr lesion.The procedure was completed with another of the same device.No patient complications resulted in relation to this event.

• 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: 11022862
• MDR Text Key: 222035836
• Report Number: 2134265-2020-17904
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2021
• Device Model Number: 3825
• Device Catalogue Number: 3825
• Device Lot Number: 15925H19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR