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); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation. A visual inspection found frayed and unraveled fibers on the balloon. The device was inflated during functional testing and water was seen exiting from the balloon. The fibers were removed, and a longitudinal rupture was identified. Therefore, the investigation is confirmed for frayed and unraveled material, as well as a longitudinal rupture. Per the reported event details, the target lesion was calcified, and a wall stent was present during the procedure. Therefore, it is possible that patient and/or procedural issues contributed to the event. However, the definitive root cause for the identified compound rupture could not be determined based upon available information.

Event Description

This report summarizes one (1) malfunction. A review of the reported information indicated that model at75186 pta balloon dilatation catheter allegedly experienced material frayed, material rupture, and unraveled material. This information was received from one source. The malfunction involved a patient with no known impact to the patient. The (b)(6) year old female patient was (b)(6) lbs.

• 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: 8808485
• MDR Text Key: 151640038
• Report Number: 2020394-2019-01625
• 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

• Device Model Number: AT75186
• Device Catalogue Number: AT75186
• Device Lot Number: GFCY2089
• 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