MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION CATHETER; PTA DILATATION CATHETER

Model Number	0254513
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
As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for evaluation; therefore, the investigation is inconclusive for material rupture.A definitive root cause for the reported event could not be determined.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 0254513 pta dilatation catheter allegedly experienced material rupture.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The age, sex and weight of the patient were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0254513 pta dilatation catheter allegedly experienced material rupture.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The age, sex and weight of the patient were not provided.
Additional Manufacturer Narrative
H10: the reported malfunction was reassessed for reportability and determined to be no longer reportable.H10: as the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for evaluation; therefore, the investigation is inconclusive for material rupture.A definitive root cause for the reported event could not be 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.

• Brand Name: TRUE DILATATION CATHETER
• Common Device Name: PTA DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10736516
• Report Number: 2020394-2020-06071
• Device Sequence Number: 13981584
• Product Code: OZT
• UDI-Device Identifier: 00801741097461
• UDI-Public: (01)00801741097461
• 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): 01/08/2021

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: 0254513
• Device Catalogue Number: 0254513
• Device Lot Number: GFDU0236
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 01/08/2021
• Patient Sequence Number: 1