MAUDE Adverse Event Report: ABBOTT VASCULAR RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 100819320

Device Problem Material Rupture (1546)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/25/2021

Event Type  Injury  

Event Description

An rx viatrac 14mm plus peripheral dilation catheter was being utilized during a peripheral angioplasty, 4-5 mm of air had been instilled when the balloon burst leaving a fragment of the device in the patient.Is therapy still on-going? no.Peripheral angioplasty.Fda safety report id # (b)(4).

• Brand Name: RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 11404480
• MDR Text Key: 234935230
• Report Number: MW5099757
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 100819320
• Device Lot Number: 80362
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2021
• 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): Life Threatening; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 109