MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number U8130330

Device Problems Break (1069); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided, therefore a lot history review was performed.The sample was returned to the manufacturer 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 u8130330 pta balloon dilatation catheter allegedly was unable to load over the guidewire and broke.This information was received from one source.This malfunction involved a patient with no consequences.Age, weight, and gender of the patient was 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 for evaluation.Therefore the investigation is confirmed for the reported device-device incompatibility.Based upon the available information, the definitive root cause for this event 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 u8130330 pta balloon dilatation catheter allegedly experienced device-device incompatibility.This information was received from one source.This malfunction involved a patient with no consequences.Age, weight, and gender of the patient was not provided.

• Brand Name: ULTRAVERSE 018 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: 10314198
• MDR Text Key: 200056306
• Report Number: 2020394-2020-04998
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741064616
• UDI-Public: (01)00801741064616
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: U8130330
• Device Catalogue Number: U8130330
• Device Lot Number: CMDY0564
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1