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

Model Number	DR4064
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
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 was received for evaluation.During visual evaluation, no kinks were noted to the catheter shaft and no anomalies to the luers, bifurcate or glue fillets.During functional testing, an in-house presto inflation device was used to inflate the balloon and water was noted leaking from the balloon.The balloon fibers were stripped and re-inflated.Leaking was noted from the distal tip.Under microscopic examination, the inner guidewire lumen was noted to have a tear and kink.No other functional testing was performed.One photo was provided and reviewed.The photo shows the dorado balloon.Liquid droplets are noted at the distal end of the balloon.No other anomalies noted.Therefore, the investigation is confirmed for the reported leak as leaking was noted from the distal tip of the balloon based on the provided photo and functional testing of the returned sample.The investigation is confirmed for the identified material split as the inner guidewire lumen was noted to have a tear and kink under microscopic examination of the returned sample.The tear noted within the inner lumen is a possible cause of the reported leak.However, a definitive root cause for the alleged leak and identified material split 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: 05/2024.
Event or Problem Description
It was reported that during an angioplasty procedure via left brachial artery, the pta balloon allegedly leaked.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 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15613647
• Report Number: 2020394-2022-00803
• Device Sequence Number: 7975297
• Product Code: LIT
• UDI-Device Identifier: 00801741058714
• UDI-Public: (01)00801741058714
• 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): 09/20/2022

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: 93SF0033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 10/17/2022
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 71 KG