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

Catalog Number	DR4064
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure in the calcified renal artery stenosis, it was found that the pta balloon allegedly leaked due to the balloon ruptured at 8 atm and could not be implanted normally.It was further reported that there was allegedly a difficulty in retracting the balloon through the introducer sheath.Furthermore, the balloon and the introducer sheath were removed together as one unit.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a video was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2025).H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that during an angioplasty procedure in the calcified renal artery stenosis, it was found that the pta balloon allegedly leaked due to the balloon ruptured at 8 atm and could not be implanted normally.It was further reported that there was allegedly a difficulty in retracting the balloon through the introducer sheath.Furthermore, the balloon and the introducer sheath were removed together as one unit.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.One video was provided and reviewed.The video shows the dorado device connected to an inflation device.Inflation of the balloon is attempted but fluid is seen leaking out of the proximal end of the guidewire hub.A drop in the pressure reading of the inflation device is also seen.No other anomalies noted.Therefore, the investigation is inconclusive for the reported balloon rupture and sheath removal difficulty as no objective evidence was provided.However, the investigation is confirmed for the identified leak as a leak was seen at the proximal end of the guidewire hub.A definitive root cause for the reported balloon rupture, sheath removal difficulty and identified leak could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• 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: 19868860
• Report Number: 2020394-2024-01132
• Device Sequence Number: 7666188
• Product Code: LIT
• UDI-Device Identifier: 00801741058714
• UDI-Public: (01)00801741058714(17)251013(10)93XG0080
• 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,Followup
• Report Date (Section B): 12/09/2024

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 Expiration Date: 10/13/2025
• Device Catalogue Number: DR4064
• Device Lot Number: 93XG0080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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