MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number U41502H15

Device Problems Break (1069); Material Deformation (2976)

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 not been returned for evaluation but three electronic photos were returned for review.The investigation confirmed for the reported material deformation but was inconclusive for the reported break.Based on the information provided, the definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model u41502h15 pta balloon dilatation catheter allegedly experienced material deformation and break.This information was received from one source.This malfunction involved a patient with no consequences.The (b)(6) year old male patient weighed (b)(6) kilograms.

Manufacturer Narrative

H10: the lot number for the malfunction was provided and a lot history review was performed.The device and photo were returned for evaluation.The investigation confirmed for material deformation and device break.A definitive root cause could not be determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model u41502h15 pta balloon dilatation catheter allegedly experienced material deformation and break.This information was received from one source.This malfunction involved a patient with no consequences.The 61 year old male patient weighed 54 kilograms.

• Brand Name: ULTRAVERSE 014 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: 9975193
• MDR Text Key: 188727381
• Report Number: 2020394-2020-03003
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741053627
• UDI-Public: (01)00801741053627
• 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: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: U41502H15
• Device Catalogue Number: U41502H15
• Device Lot Number: CMBZ0412
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/17/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 07/08/2020
• Patient Sequence Number: 1