MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD ANGIOPLASTY BALLOON; CATHETER, PERCUTANEOUS

Catalog Number ATG80144

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problem Restenosis (4576)

Event Date 03/13/2023

Event Type  Injury  

Event Description

An esrd patient that came to the office for routine angioplasty for recurrent stenosis.A bard, atlas gold 14mm x 4 cm balloon was used.During balloon inflation, the balloon completely separated from the shaft and started migrating, so it had to be stented in place.The balloon was inflated to 14 atm of pressure and not passed the stated burst pressure of 18 atm.

• Brand Name: ATLAS GOLD ANGIOPLASTY BALLOON
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.
• MDR Report Key: 16974402
• MDR Text Key: 315788585
• Report Number: MW5117731
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ATG80144
• Device Lot Number: 93PH0094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American