MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR INC ATLAS GOLD PTA DILATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number ATG80144

Device Problems Material Rupture (1546); Device Damaged by Another Device (2915)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/11/2020

Event Type  Injury  

Event Description

A bard 14 mm x 40 mm conquest balloon was introduced and balloon angioplasty of the proximal end of the left common iliac stent was performed.During subsequent inflations, the balloon ruptured likely on one of the ends of the metal stent.Upon attempted removal of the balloon catheter, the balloon sheared off of the catheter leaving the balloon in place within the femoral vein.Fda safety report id# (b)(4).

• Brand Name: ATLAS GOLD PTA DILATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR INC; tempe AZ 85281
• MDR Report Key: 10178564
• MDR Text Key: 196071934
• Report Number: MW5095090
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060755
• UDI-Public: (01)00801741060755
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: ATG80144
• Device Catalogue Number: ATG80144
• Device Lot Number: 93XD0182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 116