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

Model Number DR8086

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

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted and 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 appeared bloody and no cracks was noted on to the inflation hub.No other specific anomalies were noted.On the functional evaluation, the balloon was inflated using an in-house presto inflation device and the water starts leaking from the distal end of the balloon.Under microscopic examination glue was not fully distributed and not secured to the glue fillet, several holes were noted to the glued area.One video was reviewed.The video shows that the water was leaking from the glue fillet joint and no other anomalies were noted.Therefore, based on the video review, the reported leak can be confirmed as the water leaking from the glue fillet joint.Therefore the investigation for the reported leak can be confirmed as the water starts leaking from the glue fillet joint upon inflation.The investigation for the identified break was also confirmed as the break was noted at the glue fillet joint under the microscopic observation.Although it is likely the identified break on the glue fillet at the hub and the catheter led to the reported leak, a definitive root cause for the reported leak and the identified break 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: 06/2023).

Event Description

It was reported that during an angioplasty procedure through the left arm fistula, the hub of the pta balloon catheter was allegedly found to be leaking.The procedure was completed using another device.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 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: 12354205
• MDR Text Key: 267694097
• Report Number: 2020394-2021-01493
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741059292
• UDI-Public: (01)00801741059292
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K072283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DR8086
• Device Catalogue Number: DR8086
• Device Lot Number: 93TE0093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2020
• 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