MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ATLAS PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number AT75146

Device Problems Inflation Problem (1310); Unraveled Material (1664); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation; however, two photos were received for review.Therefore, the investigation is confirmed for the balloon deformation and the unraveled material; however, the investigation is inconclusive for the reported inflation problem.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model at75146 pta balloon dilatation catheter allegedly unraveled material, material deformation and inflation problem.The information was received from a single source.This malfunction involved one patient with no patient consequences.A male patients' age and weight was not provided.

• Brand Name: ATLAS PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10736520
• MDR Text Key: 213185926
• Report Number: 2020394-2020-06072
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062445
• UDI-Public: (01)00801741062445
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2020

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: No Information
• Device Model Number: AT75146
• Device Catalogue Number: AT75146
• Device Lot Number: GFDX0249
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/26/2020
• Type of Device Usage: N
• Patient Sequence Number: 1