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

Model Number DR4074

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

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

Event Date 11/09/2021

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure via a retrograde approach, the pta balloon allegedly had an inflation issue.It was further reported that air was heard leaking from the connection part of the balloon and the catheter shaft.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one dorado pta dilatation catheter has returned for evaluation.On the visual evaluation of the device, no other specific anomalies noted.On the functional evaluation of the device, the device was inflated with in-house presto device at 8 atm no leaks noted on the balloon or the catheter.On further the balloon inflated to 22 atm water leaking from the balloon catheter bond joint.Microscopic observation was performed and noted a circumferential break at the proximal glue joint.Therefore, the investigation has confirmed for the reported leak as the water leaks from the catheter during the functional testing.The investigation also confirmed for the identified break as a circumferential break at the proximal glue joint during the microscopic observation of the returned device for evaluation.During the microscopic observation a break was noted on the proximal glue joint on the catheter might contribute the reported leak.However, the definitive root cause for the reported leak and 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: 03/2024).

• 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: 12967478
• MDR Text Key: 281977963
• Report Number: 2020394-2021-02058
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741058974
• UDI-Public: (01)00801741058974
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DR4074
• Device Catalogue Number: DR4074
• Device Lot Number: 93PF0107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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