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

Model Number	U354054
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9591280
• Report Number: 2020394-2020-00277
• Device Sequence Number: 491677
• Product Code: LIT
• UDI-Device Identifier: 00801741092398
• UDI-Public: (01)00801741092398
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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
• Operator of Device: No Information
• Device Model Number: U354054
• Device Catalogue Number: U354054
• Device Lot Number: CMDQ0516
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 04/03/2020
• Patient Sequence Number: 1