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

Catalog Number AT75144

Device Problems Retraction Problem (1536); Material Rupture (1546); Malposition of Device (2616); Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.The lot number for the device has been provided.A review of the device history records is currently being performed.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that while post-dilating a stent, during the first inflation, the pta balloon allegedly ruptured at 18 atm in an upper arm a/v fistula.It was further reported that during retraction, the balloon catheter allegedly damaged and pulled the stent out of location.A previously implanted stent stopped the stent which allowed the balloon catheter to be retracted from the patient.Reportedly, another stent was used to treat the lesion and complete the procedure.

Manufacturer Narrative

A manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: fiber strands were noted to be unraveled 3.1cm from the distal tip.The unraveled fibers measured approximately 9.0cm in length.No other anomalies were observed along the length of the device.Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house guidewire, and it passed without issue.The inflation hub was connected to an inflation device, and an attempt was then made to inflate the balloon with water.Upon inflating, the balloon inflated asymmetrically due to the unraveled fibers and water was observed leaking through the fibers of the balloon, 4.1cm from the distal tip.The balloon was stripped of its fibers in order to locate the rupture.A pinhole rupture was found on the balloon, approximately 4.3cm from the distal tip.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the device was returned.The investigation for is confirmed for a pinhole rupture and unraveled fibers on the barrel of the balloon.The investigation is inconclusive for stent retraction issues, as functional testing could not be performed and the event could not be replicated.Labeling review: the current instructions for use (ifu)provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.

• Brand Name: ATLAS PTA BALLOON DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5414691
• MDR Text Key: 37615532
• Report Number: 2020394-2016-00156
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: AT75144
• Device Lot Number: GFZH2721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR