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

Catalog Number	DR4084
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
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 catheter was returned for evaluation.A complete circumferential break was observed on the bond joint between the catheter and balloon near to the proximal end.No specific anomalies were noted during the visual evaluation.No functional testing was performed due to the condition of the device.All the anomalies observed under microscopic observations.Although the functional testing was not performed, a bond joint break was observed between the proximal end of the catheter and the balloon.Hence, the investigation is confirmed for the reported leak and identified bond joint break.During visual and microscopic observations, a bond joint break was observed which would have contributed to the reported leak, however the definitive root cause for the reported leak and identified bond joint break 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.H10: d4 (expiry date: 03/2026).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, blood was allegedly returning into the inflation device upon negative pressure.It was further reported that another balloon 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 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: 18407773
• Report Number: 2020394-2023-01327
• Device Sequence Number: 2673701
• Product Code: LIT
• UDI-Device Identifier: 00801741059247
• UDI-Public: (01)00801741059247
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/26/2023

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 Catalogue Number: DR4084
• Device Lot Number: 93QH0157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 12/28/2023
• 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