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

Catalog Number	DR8084
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to an angioplasty procedure, the pta balloon was allegedly unable to be removed from the plastic sheath around the balloon.It was further reported that the balloon was completely detached from the catheter shaft.The procedure was completed using another device.There was no patient contact.
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 was received for evaluation with the balloon protector over the balloon with the stylet inserted through the distal tip.A complete circumferential break to the distal end of the catheter was noted.The balloon was seen separated from the catheter shaft at the proximal balloon joint.The inflation and guidewire lumens were exposed.Due to the condition of the sample, functional testing was not performed.One photo was provided and reviewed.The photo shows the dorado catheter with the balloon protector over the balloon and the stylet inserted through the distal tip of the balloon.A complete circumferential break to the distal end of the catheter is seen with the balloon separated from the catheter shaft at the proximal balloon joint.The inflation and guidewire lumens can be seen exposed.Therefore, the investigation is inconclusive for the reported difficult to remove packaging material as functional testing could not be performed due to the condition of the device.The investigation is unconfirmed for the reported detachment as no complete detachment was seen, but confirmed for the identified break as the balloon was seen separated from the catheter shaft at the proximal balloon joint.A definitive root cause for the reported difficult to remove packaging material, detachment and identified 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: 04/2026) 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.H3 other text : see h10.

• 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: 18462702
• Report Number: 2020394-2023-01364
• Device Sequence Number: 14228214
• Product Code: LIT
• UDI-Device Identifier: 00801741059254
• UDI-Public: (01)00801741059254
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/28/2023

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: DR8084
• Device Lot Number: 93QH0166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/08/2024
• 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