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

Model Number DR80104

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2021

Event Type  malfunction  

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 for evaluation.The investigation of the reported event is currently underway.(expiry date: 07/2024).

Event 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.

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 returned for evaluation.No specific anomalies noted on the visual evaluation.A complete circumferential break noted on bond joint of the returned balloon and kinks was also noted on the inner guide wire lumen.No functional testing performed due to the condition of the device and nature of the complaint.No evidence of balloon or catheter detachment noted on the returned device.All the anomalies noted on the microscopic observation.Therefore, investigation for reported balloon detachment was unconfirmed as no evidence of balloon or catheter detachment on the returned device.However, the investigation was confirmed for the balloon bond joint break as a complete circumferential break noted on bond joint of the returned balloon.A definitive root cause for the balloon detachment and balloon bond joint 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 (method).H11: h6 (result, conclusion).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 : see h10.

Event 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
• Type of Device: 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: 12742753
• MDR Text Key: 279809189
• Report Number: 2020394-2021-01936
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741059544
• UDI-Public: (01)00801741059544
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DR80104
• Device Catalogue Number: DR80104
• Device Lot Number: 93UF0062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1