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

Model Number	DR8064
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 both of the reported malfunctions, the devices are pending return to bd 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 two malfunctions.A review of the reported information indicated that model dr8064 pta balloon dilatation catheter allegedly experienced a material rupture.This information was received from various sources.The two malfunctions involved a patient with no known impact to the patient.Of the two malfunctions, two were male ranging between 30 and 51 years-old, both weighed (b)(6) kg.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model dr8064 pta balloon dilatation catheter allegedly experienced a material rupture.This information was received from various sources.The two malfunctions involved a patient with no known impact to the patient.Of the two malfunctions, two were male ranging between 30 and 51 years-old, both weighed 55 kg.
Additional Manufacturer Narrative
H10: for both of the reported malfunctions, as the lot number for the devices were not provided, a manufacturing review could not be performed.The samples were not returned to the manufacturer for inspection/evaluation.Therefore, the investigations of the reported events were inconclusive.Based upon the available information, the definitive root cause for the events are 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.
Additional Manufacturer Narrative
H10: for one of the reported malfunctions, the initially reported issue was determined to be a leak instead of a rupture.Therefore, this malfunction was reassessed and determined to be not reportable.H10: for the remaining malfunction, the lot number was not provided, therefore a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for the events are unknown.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 dr8064 pta balloon dilatation catheter allegedly experienced a material rupture.This information was received from various sources.The malfunction involved a patient with no known impact to the patient.The male patient was 51 years old and weighed 55 kgs.

• Brand Name: DORADO 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: 9215386
• Report Number: 2020394-2019-04168
• Device Sequence Number: 387765
• Product Code: DQY
• UDI-Device Identifier: 00801741058721
• UDI-Public: (01)00801741058721
• 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,Followup
• Report Date (Section B): 07/01/2020

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: DR8064
• Device Catalogue Number: DR8064
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019; 06/30/2020
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 01/09/2020; 07/01/2020
• Patient Sequence Number: 1