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

Model Number AT75222

Device Problems Device Markings/Labelling Problem (2911); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the reported malfunction was provided, therefore a lot history review will be performed.The device was not returned for evaluation, however one video was provided for review.The company is still investigating the issue at this time.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model at75222 pta balloon dilatation catheter experienced material deformation.This report was received from one source.One patient was involved with no reported patient injury.The patient's age, weight, and gender were not provided.

Manufacturer Narrative

H10: the lot number for the reported malfunction was provided, therefore a lot history review was performed.The device was not returned for evaluation, however one video was provided for review.The investigation of the video unconfirmed the alleged malfunction of mislabeled product.Based on the provided information, a definitive root cause of the event could not be determined.The device is labeled for single use.H11:section a through f - the information provided by bd 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 bd.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model at75222 pta balloon dilatation catheter experienced product mislabeling.This report was received from one source.One patient was involved with no reported patient injury.The patient's age, weight, and gender were not provided.

• 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
• MDR Report Key: 10286720
• MDR Text Key: 199246657
• Report Number: 2020394-2020-04536
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062537
• UDI-Public: (01)00801741062537
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AT75222
• Device Catalogue Number: AT75222
• Device Lot Number: GFBW2433
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1