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

Catalog Number AT75142

Device Problems Structural Problem (2506); Device Markings/Labelling Problem (2911)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2015

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.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.Device not returned.

Event Description

It was reported during a laryngeal dilatation, a pta balloon appeared to be longer under guided fluoroscopy than what was labeled on the package.The health care provider reported this was the second balloon used in a series of three balloons for the progressive dilatation, and the third pta balloon was used to successfully complete the procedure.There was no reported consequence or impact to the patient.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: one electronic photo was reviewed.The photo shows what appears to be an atlas balloon with an atlas outer carton labeling in the background.The label on the carton indicates catalog number at-75142, with a 14mm balloon diameter and 2cm balloon length.The first three letters of the lot number are visible in the photo and indicates that the lot number starts with gfy.The balloon shown in the photo appears to have been previously inflated.The balloon was not inflated; therefore, a measurement of the balloon barrel (body) cannot be determined from the photo.The marker bands cannot be seen underneath the balloon fibers; therefore, a measurement of the distance between the marker bands cannot be determined from the photo.Based on the photo provided, the complaint investigation is inconclusive for a device markings issue.Conclusion: the device was not returned.One photo was provided for review.Based upon the photo provided, the investigation is inconclusive for the alleged mislabeling, as the measurement for the balloon length and distance between the marker bands could not be determined from the photo.The balloon length consists of only the balloon barrel (body) which does not include the distal and proximal cone.As such, it is unknown if the user perceived the balloon length to include both distal and proximal cone.In addition, the user facility orders both 14mm x 2cm and 14mm x 4cm atlas balloons.Therefore, in the event that there was a mix-up, it is possible that it occurred at the user facility.It is unknown if procedural issues contributed to the reported event.Labeling review: the current ifu (instructions for use) states: precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.Dilatation catheter preparation: remove catheter from package.Verify the balloon size is suitable for the procedure and the selected accessories accommodate the catheter as labeled.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.

• Brand Name: ATLAS PTA 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: 5158208
• MDR Text Key: 28839656
• Report Number: 2020394-2015-01719
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: AT75142
• Device Lot Number: GFYG2484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2014
• 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 Age: 63 YR
• Patient Weight: 77