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

Model Number	DR4074
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Frayed (1262); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Additional 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 was returned for evaluation.Frayed fibers were noted on the balloon; no other anomalies were noted on the returned device.On the functional evaluation the device was inflated with an in-house presto inflation device and water was noted leaking from the distal tip.Then the balloon was cut and under the microscope it was noted a partial break in the inner guide wire lumen.No other testing was performed.No evidence of balloon rupture noted during the functional testing.One video was reviewed.The balloon was noted to be bloody and noted to be in an inflated position.Water was leaking from the guide wire luer; however, the source of the leak is unknown.No evidence of balloon rupture noted on submitted video.Therefore, based on the video review, the reported balloon rupture remains inconclusive.Therefore, the investigation for the reported balloon rupture remains inconclusive as there is no evidence of balloon rupture noted during functional testing and the submitted video.However, the investigation was confirmed for the identified inner guide lumen rupture as a partial break on the inner guide wire lumen noted during the microscopic observation.The investigation was also confirmed for identified frayed fibers as frayed fibers were noted on the balloon during the visual evaluation.A definitive root cause for the reported balloon rupture and identified inner guide wire lumen rupture and frayed fibers 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: 08/2022).
Event or Problem Description
It was reported that during an angioplasty procedure in the internal jugular vein, the balloon allegedly ruptured at 10 atm.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: DORADO
• Common Device Name: 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: 13684091
• Report Number: 2020394-2022-00145
• Device Sequence Number: 12254530
• Product Code: LIT
• UDI-Device Identifier: 00801741058974
• UDI-Public: (01)00801741058974
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/02/2022

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: DR4074
• Device Catalogue Number: DR4074
• Device Lot Number: 93VD0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2019
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 58 KG