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

Model Number	U357578
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported malfunction, a lot number was provided, and a lot history review was performed.The sample's return is still pending.The company is still investigating the issue at this time.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 u357578 pta balloon dilatation catheter allegedly experienced material rupture.This report was received from a single source.This malfunction involved a patient with no patient consequences.The reported male patient was (b)(6) years of age and (b)(6) lbs.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u357578 pta balloon dilatation catheter allegedly experienced material rupture.This report was received from a single source.This malfunction involved a patient with no patient consequences.The reported male patient was 48 years of age and 165 lbs.
Additional Manufacturer Narrative
H10.For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.Balloon rupture, and retraction issue was confirmed for the device.A root cause has not been determined.The device was labeled for single use.H10:g4 h11: h2, h6 (device, results, conclusion) 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: 9598088
• Report Number: 2020394-2020-00546
• Device Sequence Number: 19438887
• Product Code: LIT
• UDI-Device Identifier: 00801741093470
• UDI-Public: (01)00801741093470
• 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): 04/02/2020

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: U357578
• Device Catalogue Number: U357578
• Device Lot Number: CMDT0189
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 04/02/2020
• Patient Sequence Number: 1