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

Model Number	DR8054
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 1 malfunction event.A review of the event indicated that model dr8054 pta dilatation catheter experienced an uncomplicated balloon rupture and a break.This report was received from a single source.The event involved a patient with no reported injury.The patient age, weight, and sex were not provided.
Additional Manufacturer Narrative
H10: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.The device was returned for evaluation.An attempt was made to inflate the device and water was seen exiting the catheter shaft from a partial circumferential break in the catheter shaft.Therefore, the investigation is confirmed for a break.Due to the break, the balloon was unable to be fully inflated to functionally test for the reported rupture.Therefore, the investigation is inconclusive for the reported rupture.The definitive root cause for the partial break or reported rupture could not be determined based upon available information.The device is labeled for single use.H10: g4 h11: h6 (results, conclusions) 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 1 malfunction event.A review of the event indicated that model dr8054 pta dilatation catheter experienced an uncomplicated balloon rupture and a break.This report was received from a single source.The event involved a patient with no reported injury.The patient age, weight, and sex were not provided.

• Brand Name: DORADO PTA BALLOON DIALATATION 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: 8509804
• Report Number: 2020394-2019-00270
• Device Sequence Number: 11120885
• Product Code: DQY
• UDI-Device Identifier: 00801741058493
• UDI-Public: (01)00801741058493
• 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): 07/23/2019

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: DR8054
• Device Catalogue Number: DR8054
• Device Lot Number: 93ZC0008
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1