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

Model Number	DR8054
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 07/2024).
Event or Problem Description
It was reported that during an ultrasound guided angioplasty procedure via the right upper arm, the pta balloon was allegedly ruptured at the distal end.It was further reported that the device was difficult to remove from the introducer sheath.The procedure was completed using another device.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: the physical device was not returned for evaluation.Two photos were reviewed.The first photo shows the catheter having a bond joint break between the balloon and catheter.No other anomalies noted.The second photo shows incident report of the complaint.Therefore, based on the photos review the reported balloon rupture and difficult to remove will be remains inconclusive.However, the identified bond joint break can be confirmed.Therefore, the investigation for the reported balloon rupture and difficult to remove remains inconclusive as no evidence could noted on the provided photos.However, the investigation is confirmed for the identified break as a bond joint failure between the catheter and balloon was noted on the submitted photos.The identified bond joint break might be contributed to the reported difficult to remove.However the definitive root cause for the reported balloon rupture and difficult to remove and identified 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: 07/2024), g3, h6 (device).H11: h6 (method, result, conclusion).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 not returned.
Event or Problem Description
It was reported that during an ultrasound guided angioplasty procedure via the right upper arm, the pta balloon allegedly ruptured at the distal end.It was further reported that the device was difficult to remove from the introducer sheath.The procedure was completed using another device.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
• 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: 14494705
• Report Number: 2020394-2022-00405
• Device Sequence Number: 17646950
• Product Code: LIT
• UDI-Device Identifier: 00801741058493
• UDI-Public: (01)00801741058493
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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: DR8054
• Device Catalogue Number: DR8054
• Device Lot Number: 93UF0105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 64 YR
• Patient Sex: Female