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

Model Number AT75166

Device Problems Material Frayed (1262); Material Rupture (1546); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for the malfunction and a lot history review was performed.The device was returned for evaluation and investigation is confirmed for reported unraveled balloon material, frayed fiber, fiber disturbance, balloon rupture and peeled coating.A definitive root cause could not be determined.The device is labeled for single use.(b)(4).

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model at75166 pta dilatation catheter allegedly experienced balloon rupture, frayed fibers, peeled coating, fiber disturbance and unraveled balloon.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were 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: 10299763
• MDR Text Key: 199653129
• Report Number: 2020394-2020-04693
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062476
• UDI-Public: (01)00801741062476
• 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: 07/20/2020

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: AT75166
• Device Catalogue Number: AT75166
• Device Lot Number: GFDZ2379
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/20/2020
• Type of Device Usage: Initial
• Patient Sequence Number: 1