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 devices were both returned for evaluation. A visual inspection found frayed fibers on the balloons. The devices were inflated during functional testing and water was seen exiting from the balloons. The fibers were removed, and a longitudinal rupture was identified on the first device; pinhole rupture was identified on the second. Therefore, the investigation is confirmed for frayed material, as well as a longitudinal rupture. Per the reported event details, a wall stent was present during the procedures. Therefore, it is possible that patient and/or procedural issues contributed to the alleged malfunctions. However, the definitive root cause for the identified frayed material and longitudinal rupture could not be determined based upon available information.

Event Description

This report summarizes two malfunctions. A review of the reported information indicated that material on model at75186 atlas pta dilatation catheters allegedly frayed and ruptured. This information was received from various sources. The alleged malfunctions each involved a patient with no known impact to the patient. Both patients were reported to be female, one patient was reported to be (b)(6)-years-old and weigh (b)(6)lb; the other was reported to be (b)(6) -years-old and weigh (b)(6) lb.

• 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: 8809601
• MDR Text Key: 151740508
• Report Number: 2020394-2019-01640
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/19/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 07/19/2019
• 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: GFCZ1773, GFCY2820
• Was Device Available For Evaluation?: No Answer Provided

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/30/2019
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided

Is this a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial