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

Model Number	DR4064
Medical Device Problem Codes	Break (1069); Inflation Problem (1310); Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 03/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the device balloon allegedly failed to inflate at 24 atm.It was further reported that contrast medium allegedly leaked from shaft of balloon proximal or guidewire lumen.Reportedly, another pta balloon was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the device balloon allegedly failed to inflate at 24 atm.It was further reported that contrast medium allegedly leaked from shaft of balloon proximal or guidewire lumen.Reportedly, another pta balloon was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 catheter has returned for evaluation.On the visual evaluation it appeared bloody, no other specific anomalies noted.On the functional evaluation of the device, the guide-wire lumen has flushed, and an in-house guide wire has passed though the catheter without any issue.The balloon was attempted to be inflated with in-house presto inflation device.The balloon inflated to nominal pressure and no leaks were noted with the balloon shape held uniformly.The balloon was then inflated to rbp, and water leaks were noted at the proximal joint of the catheter and balloon.The balloon did not hold the pressure, then the balloon was inflated again to nominal pressure and deflated without any issue.The balloon was then inflated to rbp however the balloon would not hold this pressure as it was noted that water was exiting from the proximal joint.Under microscopic examination a partial break was noted to the proximal joint.Therefore, the reported inflation issue is confirmed as the balloon didn't maintain the pressure at rbp, the investigation also identified break and reported leak was confirmed as partial break was noted at the proximal joint at the catheter.The identified the glue joint break noted during evaluation most likely contributed to the reported leak and inflation issue.However the definitive root cause could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 03/2023).H11: h6 (device, result, conclusion).H11: section a through f ¿ the information provide 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 PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10973838
• Report Number: 2020394-2020-20777
• Device Sequence Number: 17208051
• 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,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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: 93PE0095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Weight: 53