MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER; PTA BALLOON DILATATION CATHETER

Model Number U35130520

Device Problems Difficult to Remove (1528); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/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 u35130520 pta dilatation catheter allegedly experienced retraction problem and difficult to remove.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The age, sex and weight of the patient 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 returned to the manufacturer for evaluation.Therefore, the investigation is confirmed for the reported retraction problem.Based on the available information, the definitive root cause is unknown.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 indicated that model u35130520 pta dilatation catheter allegedly experienced retraction problem.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The age, sex and weight of the patient were not provided.

• Brand Name: ULTRAVERSE 035 PTA 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: 10744705
• MDR Text Key: 213404449
• Report Number: 2020394-2020-06168
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741092732
• UDI-Public: (01)00801741092732
• 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: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: U35130520
• Device Catalogue Number: U35130520
• Device Lot Number: CMDT0574
• Date Manufacturer Received: 12/31/2020
• Patient Sequence Number: 1