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

Model Number	DR80104
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
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 been returned to the manufacturer.The investigation of the reported event is currently underway.(expiry date: 06/2024).
Event or Problem Description
It was reported that during a pta procedure through the basilic vein, the balloon allegedly tore out the catheter.It was further reported that the balloon got separated from the catheter and was difficult to be removed.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: one dorado pta dilatation catheter has been returned for the evaluation.On the visual evaluation, a complete circumferential break was noted on the bond joint of the balloon and no other specific anomalies were noted.No other functional testing was performed due to the condition of the device and nature of the complaint.Further, no evidence of balloon or catheter detachment noted on the returned device.All the anomalies were noted on the microscopic observation.Therefore, investigation for the reported balloon detachment was unconfirmed as no evidence of balloon or catheter detachment noted on the returned device.The investigation for the identified bond joint break of the balloon was confirmed, as a complete circumferential break noted on bond joint of the returned balloon.A definitive root cause for the reported balloon detachment and the identified bond joint break of the balloon 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: (expiry date: 06/2024).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: see h10.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly tore out the catheter.It was further reported that the device detached and was difficult to be removed.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: DORADO PTA DILATATION CATHETER
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12742752
• Report Number: 2020394-2021-01935
• Device Sequence Number: 17356572
• Product Code: LIT
• UDI-Device Identifier: 00801741059544
• UDI-Public: (01)00801741059544
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/18/2021

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: DR80104
• Device Catalogue Number: DR80104
• Device Lot Number: 93TF0070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 11/26/2021
• 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