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

Model Number	DR4064
Medical Device Problem Codes	Break (1069); Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
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 has been received for the evaluation.On the visual evaluation, the device was noted bloody and no other visual anomalies were noted.On the functional evaluation, the balloon was inflated to 8 atm using an in-house presto inflation device.Further, the balloon maintained pressure and no water was noted to be leaking from the glue joint.The balloon was then inflated to 24atm again the balloon maintained pressure but water was noted to be leaking at the proximal balloon joint.Under the microscopic observation, the circumferential break was noted at the proximal balloon joint.No other functional testing was performed.Therefore the investigation for the reported inflation issue and leakage was confirmed, as the water was noted leaking at the proximal balloon joint during the functional testing.The investigation for the identified balloon joint break was also confirmed, as the circumferential break was noted at the proximal balloon joint under the microscopic observation.The identified balloon joint break is likely the root cause for the reported inflation issue and leakage.However, the definitive root cause for the reported inflation issue, leakage and the identified balloon joint 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: 02/2024).
Event or Problem Description
It was reported that during an angioplasty procedure via retrograde approach, the pta balloon allegedly had 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.

• 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: 13173951
• Report Number: 2020394-2022-00008
• Device Sequence Number: 11883499
• Product Code: LIT
• UDI-Device Identifier: 00801741058714
• UDI-Public: (01)00801741058714
• 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): 01/03/2022

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: DR4064
• Device Catalogue Number: DR4064
• Device Lot Number: 93PF0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/06/2022
• 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