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

Model Number	DR8074
Medical Device Problem Codes	Break (1069); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 10/2023).
Event or Problem Description
It was reported that during an angioplasty procedure of the shunt, the pta balloon allegedly failed to inflate.It was further reported that another device was used to complete the procedure.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: one dorado pta dilatation catheter has been received for the evaluation.On the visual evaluation, the device was noted to be bloody and no other specific anomalies were noted to the device.On the functional evaluation, an inhouse presto inflation device was used to inflate the sample and water was noted to be leaking from the glue joint.Under the microscopic observation, the circumferential break was noted at the proximal balloon joint.No other functional testing performed.Therefore the investigation for the reported inflation issue was confirmed, as the water starts leaking from the circumferential break at the proximal balloon joint upon inflation.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.However, the definitive root cause for the reported inflation issue 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.H10: d4 (expiry date: 10/2023), h11: h6 (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.H3 other text : see h10.
Event or Problem Description
It was reported that during an angioplasty procedure of the shunt, the pta balloon allegedly failed to inflate.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
• MDR Report Key: 12496877
• Report Number: 2020394-2021-01756
• Device Sequence Number: 3376156
• Product Code: LIT
• UDI-Device Identifier: 00801741058981
• UDI-Public: (01)00801741058981
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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: DR8074
• Device Catalogue Number: DR8074
• Device Lot Number: 93WE0122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1