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

Model Number	DR4064
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); 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 three malfunctions and lot history reviews were performed.Of the three malfunctions, one device was returned for evaluation and the investigation is currently underway.The investigation for the other two malfunction is inconclusive as the device were not returned.A root cause could not be determined.The devices are labeled for single use.
Event or Problem Description
This report summarize three malfunction.The information reviewed indicated that model dr4064 pta balloon dilatation catheter allegedly experienced material rupture.The information was received from various sources.The malfunctions involved patients with no reported consequences.Patient information was not provided.
Event or Problem Description
This report summarize three malfunctions.The information reviewed indicated that model dr4064 pta balloon dilatation catheter allegedly experienced material rupture.The information was received from various sources.The malfunctions involved patients with no reported consequences.Patient information was not provided.
Additional Manufacturer Narrative
H10: the lot number was provided for the three malfunctions and lot history reviews were performed.Of the three malfunctions, two devices were returned for evaluation and the investigation was confirmed for leak and break.The investigation for the other one malfunction is inconclusive as the device was not returned.A definitive root cause could not be determined.The devices are labeled for single use.H10: g4.H11: g1, h6(results, conclusion).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: DORADO PTA BALLOON DILATATION CATHETERS
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9965398
• Report Number: 2020394-2020-02801
• Device Sequence Number: 2749718
• Product Code: DQY
• UDI-Device Identifier: 00801741058714
• UDI-Public: (01)00801741058714
• 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): 07/10/2020

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: DR4064
• Device Catalogue Number: DR4064
• Device Lot Number: 93TD0147, 93TD0122
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 07/10/2020
• Patient Sequence Number: 1