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

Model Number	DR8054
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure in the superficial femoral artery via an ipsilateral antegrade approach, the contrast medium allegedly leaked from the hub of the catheter at 14 atm.It was further reported that another device was used to complete the procedure.There was no reported patient injury.
Additional 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 was returned for evaluation.On visual evaluation of the device, no specific anomalies noted.Upon functional evaluation, the device was inflated with an in-house presto device to14 atm and water was noted to be leaking from the balloon bond joint to the catheter.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 bond joint to balloon 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: 04/2024).

• Brand Name: DORADO
• Common Device Name: 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: 13987259
• Report Number: 2020394-2022-00247
• Device Sequence Number: 5568442
• Product Code: LIT
• UDI-Device Identifier: 00801741058493
• UDI-Public: (01)00801741058493
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2022

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: Health Professional
• Device Model Number: DR8054
• Device Catalogue Number: DR8054
• Device Lot Number: 93RF0113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 04/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown