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

Model Number ATG120142

Device Problems Break (1069); Inflation Problem (1310); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation identified a break, a leak, inflation issue, and material puncture.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.(b)(4).

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model atg120164 pta balloon dilatation catheter allegedly experienced a break, leak, inflation issue, and material puncture.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a (b)(6) year-old female weighing (b)(6) lbs.

Manufacturer Narrative

H10: the lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation confirmed a break, a leak, and an inflation issue.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H10: g4 h11: h6 (results) (removed device code 1504 - material puncture) 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 indicated that model atg120164 pta balloon dilatation catheter allegedly experienced a break, leak, inflation issue, and material puncture.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a 9-year-old female weighing 50 lbs.

• Brand Name: ATLAS GOLD 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: 9592088
• MDR Text Key: 178748786
• Report Number: 2020394-2020-00310
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060748
• UDI-Public: (01)00801741060748
• 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: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ATG120142
• Device Catalogue Number: ATG120164
• Device Lot Number: 93ZC0059
• Date Manufacturer Received: 03/25/2020
• Patient Sequence Number: 1