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

Model Number AT75186

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review will be performed.The device was returned for evaluation.A visual inspection was performed and frayed fibers were noticed on the balloon.No other anomalies were noted to the device.The balloon was attempted to be inflated, but it was unable to be due to dried blood in the sheath.Therefore, the investigation is confirmed for the identified frayed fibers, as fraying fibers were found on the balloon.The balloon rupture investigation is inconclusive, as the device was unable to be tested.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.

Event Description

This report summarizes two (2) malfunction.A review of the reported information indicated that model at75186 pta balloon dilatation catheter allegedly experienced material frayed and a material rupture.This information was received from one source.The malfunctions involved one patient with no known impact to the patient.The (b)(6) year old female patient was (b)(6).

• 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: 8824117
• MDR Text Key: 152193324
• Report Number: 2020394-2019-01829
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741062506
• UDI-Public: (01)00801741062506
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AT75186
• Device Catalogue Number: AT75186
• Device Lot Number: GFCY2820
• Date Manufacturer Received: 06/30/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1