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

Catalog Number	DR4084
Medical Device Problem Codes	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	09/19/2023
Type of Reportable Event	Malfunction
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 return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: (b)(6) 2025.H11: section a through f - the information provided by bd represents all of 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 : device pending return.
Event or Problem Description
It was reported that prior to an angioplasty procedure, the pta balloon was allegedly would not release from the protective sheath in the packaging.It was further reported that the balloon was pulled off with kelly¿s forceps and the balloon allegedly got pulled away and was completely detached from the catheter.The procedure was completed using another device.There was no patient contact.
Event or Problem Description
It was reported that prior to an angioplasty procedure, the pta balloon allegedly would not release from the protective sheath in the packaging.It was further reported that the balloon was pulled off with kelly¿s forceps and the balloon allegedly got pulled away and was completely detached from the catheter.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 without its balloon protector.Complete circumferential detachment was noted to the catheter shaft at the glue joint proximal to the balloon.The balloon was returned detached from the catheter shaft leaving the inner guide wire and inflation lumen wires exposed.No functional testing was performed due to the nature of the complaint.Therefore, the investigation is inconclusive for the reported difficult to remove packaging material as no evidence of the failure could be determined.However, the investigation is confirmed for the reported detachment as the balloon was noted completely detached from the catheter shaft at the bond joint.A definitive root cause for the reported difficult to remove packaging material and detachment 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: 02/2025), g3.H11: section a through f - the information provided by bd represents all of 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 AZ 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: 17936773
• Report Number: 2020394-2023-00862
• Device Sequence Number: 6595482
• 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,Followup
• Report Date (Section B): 02/08/2024

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 Catalogue Number: DR4084
• Device Lot Number: 93PG0051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 10/14/2023
• Supplement Report FDA Received Date: 02/09/2024
• 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