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

Model Number U354054

Device Problems Inflation Problem (1310); Material Rupture (1546); Material Split, Cut or Torn (4008)

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 will be performed.The device has been returned for evaluation; the evaluation identified material split, cut, or torn.Based upon the available information, a 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 u354054 pta balloon dilatation catheter allegedly experienced an inflation issue and material rupture.This information was received from one source.The malfunction involved one patient with no patient consequences.The age, weight, and gender of the patient were not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model u354054 pta balloon dilatation catheter allegedly experienced an inflation issue and material split, cut, or torn.This information was received from one source.The malfunction involved one patient with no patient consequences.The age, weight, and gender of the patient were not provided.

Manufacturer Narrative

H10: the malfunction was reassessed for reportability and determined to be no longer reportable.The lot number for the malfunction was provided and a lot history review will be performed.The device has been returned for evaluation; the evaluation confirmed inflation issue and material split, cut, or torn but is unconfirmed for material rupture.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.H10: g4 h11: b5; h6 (device) 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.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.

• 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: 9591280
• MDR Text Key: 179311404
• Report Number: 2020394-2020-00277
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741092398
• UDI-Public: (01)00801741092398
• 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: 04/03/2020

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: U354054
• Device Catalogue Number: U354054
• Device Lot Number: CMDQ0516
• Date Manufacturer Received: 03/31/2020
• Patient Sequence Number: 1