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

Model Number DR4054

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one dorado pta dilatation catheter has been received for the evaluation.On the visual evaluation, the device was appeared bloody and no other anomalies were noted.On the functional evaluation, the balloon was inflated to 8 atm using an in-house presto inflation device.Balloon maintained pressure and no water was noted to be leaking from the balloon, catheter and guidewire luer.Once the presto reached above 12 atm water was noted leaking from the guide-wire luer.A hemostat was placed on the catheter due to the issue being with the bifurcate and the presto was then pressurized again to view the bifurcate.Microscopic photos and video were taken noting a hole within the bifurcate.Therefore the investigation for the reported leak was confirmed, as the water was noted leaking from the guidewire luer during the functional evaluation.The investigation for the identified bifurcate break was also confirmed, as the water was noted leaking from the hole in the bifurcate.The identified bifurcate break is likely the root cause for the reported leak.However a definitive root cause for the identified bifurcate break and the reported leak could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 01/2024).

Event Description

It was reported that during an angioplasty procedure, the contrast medium allegedly leaked from the guidewire lumen.It was further reported that another pta balloon was used to complete the procedure.There was no reported patient injury.

• Brand Name: DORADO
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13279275
• MDR Text Key: 284019393
• Report Number: 2020394-2021-02179
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741058486
• UDI-Public: (01)00801741058486
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2021

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
• Device Operator: Health Professional
• Device Model Number: DR4054
• Device Catalogue Number: DR4054
• Device Lot Number: 93NF0059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male