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

Model Number	U41502H30
Medical Device Problem Code	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 event, lot number was provided, and lot history review being performed.The sample was returned for evaluation.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 indicates that model u41502h30 pta balloon dilatation catheter allegedly experienced balloon rupture.The information was received from one source.One patient was involved with no reported patient injury.The male patient is (b)(6) years old and weighs (b)(6) pounds.
Additional Manufacturer Narrative
H10: for the reported event, lot number was provided, and lot history review being performed.The sample was not returned for evaluation.The investigation is inconclusive for the reported balloon rupture.A root cause has not been determined.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 or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model u41502h30 pta balloon dilatation catheter allegedly experienced balloon rupture.The information was received from one source.One patient was involved with no reported patient injury.The male patient is 77 years old and weighs 202 pounds.

• Brand Name: ULTRAVERSE 014 PTA DILATATION 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: 10310777
• Report Number: 2020394-2020-04954
• Device Sequence Number: 10968893
• Product Code: LIT
• UDI-Device Identifier: 00801741064449
• UDI-Public: (01)00801741064449
• 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): 10/15/2020

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: U41502H30
• Device Catalogue Number: U41502H30
• Device Lot Number: CMDY0077
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 10/15/2020
• Patient Sequence Number: 1