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

Model Number	U4150515
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
The lot number was provided for the reported malfunction; therefore, a lot history review was performed.The device was not returned for evaluation.The investigation was inconclusive for the reported balloon rupture.A definitive root cause has not been determined.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 u4150515 pta balloon dilatation catheter allegedly experienced pinhole balloon rupture.The information was received from one source.One patient was involved with no reported patient injury.The male patient (b)(6) and age not provided.
Additional Manufacturer Narrative
H10: the reported malfunction was reassessed for reportability and determined to be no longer reportable.H10: the lot number was provided for the reported malfunction; therefore, a lot history review was performed.The device was not returned for evaluation.The investigation was inconclusive for the reported balloon rupture.Based on the available information, the definitive root cause for this event is unknown.The devices are 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 u4150515 pta balloon dilatation catheter allegedly experienced material rupture.The information was received from one source.One patient was involved with no reported patient injury.The male patient weighs 204 pounds and age not provided.

• 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: 10308137
• Report Number: 2020394-2020-04881
• Device Sequence Number: 3370717
• Product Code: LIT
• UDI-Device Identifier: 00801741064562
• UDI-Public: (01)00801741064562
• 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): 10/19/2020

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: U4150515
• Device Catalogue Number: U4150515
• Device Lot Number: CMDX0113
• 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: 10/19/2020
• Patient Sequence Number: 1