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

Catalog Number	DR8064
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to an angioplasty procedure, the bottom half of the device was found to be a golden yellow color and the package had absorbed some oil.It was further reported that the product allegedly look like soaked with oil.There was no patient contact.
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: 04/2026).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: device pending return.
Event or Problem Description
It was reported that prior to an angioplasty procedure, the bottom half of the device was found to be a golden yellow color and the package had absorbed some oil.It was further reported that the product was allegedly soaked with a popcorn oil color.There was no patient contact.
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: the sample was returned for evaluation.The sample was returned in full packaging.Discoloration was observed to the outer packaging box.The inner packaging was removed, and the same discoloration was noted to the inner packaging.The sample packaging was returned sealed.No other anomalies were noted to the returned sample.Therefore, the investigation is confirmed for the reported contamination, as an unknown discoloration staining was noted to the inner and outer packaging of the returned sample.However, the definitive source of the stain could not be determined.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiry date: 04/2026), g3.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
• 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: 17981932
• Report Number: 2020394-2023-00927
• Device Sequence Number: 11642290
• Product Code: LIT
• UDI-Device Identifier: 00801741058721
• UDI-Public: (01)00801741058721
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: DR8064
• Device Lot Number: 93RH0139
• 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: 09/28/2023
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 10/21/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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