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

Model Number	U415034
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The company is still investigating the issue currently.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 u415034 pta balloon dilatation catheter allegedly detached and was secured using a stent.There was no reported patient injury.This information was received from one source.The patient was an (b)(6) year-old male who weighed (b)(6) pounds.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u415034 pta balloon dilatation catheter allegedly ruptured, detached, and was secured using a stent.There were no consequences to the one patient involved.This information was received from one source.The patient was an 85-year-old male who weighed 145 pounds.
Additional Manufacturer Narrative
H10: the malfunction was reassessed for reportability and determined to be reportable, as a serious injury, and was reported under emdr 2020394-2019-04046.H10: the lot number for the one malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation identified material rupture and detached material.Based upon the available information, the definitive root cause is unknown.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.

• 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: 8817082
• Report Number: 2020394-2019-01750
• Device Sequence Number: 3109293
• Product Code: LIT
• UDI-Device Identifier: 00801741053689
• UDI-Public: (01)00801741053689
• 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): 10/18/2019

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: U415034
• Device Catalogue Number: U415034
• Device Lot Number: CMDN0353
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 10/18/2019
• Patient Sequence Number: 1