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

Model Number AT75144

Device Problem Expiration Date Error (2528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided and a lot history review was performed.The sample was not returned for evaluation, however, the report indicated that bd allegedly provided the customer with expired product prior to the start of the procedure.The investigation confirmed for the expiration date error.The definitive root cause is determined to be user-related.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model at75144 pta balloon dilatation catheter allegedly experienced an expiration date error.This information was received from one source.One patient was involved and there was no reported patient injury.Patient information 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: 9194963
• MDR Text Key: 162449537
• Report Number: 2020394-2019-03973
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741062438
• UDI-Public: (01)00801741062438
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AT75144
• Device Catalogue Number: AT75144
• Device Lot Number: GFAT2534
• Date Manufacturer Received: 09/30/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1