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

Model Number ATG80186

Device Problems Break (1069); Deflation Problem (1149); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.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 indicated that model atg80186 pta balloon dilatation catheter allegedly would not fully deflate, had difficulty retracting through the sheath, and broke.No further treatment was needed.There was no reported patient injury.This information was received from one source.The patient was a (b)(6) year-old female who weighed (b)(6) pounds.

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 retraction issues and a material break and was inconclusive for deflation issues.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H11: b5, h6 (results, conclusion).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 atg80186 pta balloon dilatation catheter allegedly would not fully deflate, had difficulty retracting through the sheath, and broke.This information was received from one source.There was one patient involved with no patient consequences.The patient was a 65-year-old female who weighed 140 pounds.

• 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: 8816691
• MDR Text Key: 151882449
• Report Number: 2020394-2019-01744
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060892
• UDI-Public: (01)00801741060892
• 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: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ATG80186
• Device Catalogue Number: ATG80186
• Device Lot Number: 93TC0139
• Date Manufacturer Received: 09/30/2019
• Patient Sequence Number: 1