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

Model Number AT75202

Device Problem Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device for this event has been returned to the manufacturer for evaluation.The investigation identified unraveling balloon fibers.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that an at75202 pta balloon dilatation catheter allegedly experienced unraveled material.This information was received from one source.The unraveled material involved one patient with no patient consequence.The age, weight, and sex were not reported for the patient involved.

• 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8809667
• MDR Text Key: 151739009
• Report Number: 2020394-2019-01641
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741062513
• UDI-Public: (01)00801741062513
• 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: 07/19/2019

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: AT75202
• Device Catalogue Number: AT75202
• Device Lot Number: GFAV3633
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/19/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1