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

Model Number	DR8074
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 01/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the hub of the guidewire allegedly detached after the first inflation attempt.It was further reported that another balloon was used to complete the procedure.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 detached at the guidewire luer connection has returned for evaluation.On the visual evaluation of the device, it appeared bloody and the guide wire hub found detached from the catheter.Microscopic observation also confirms the hub detachment and the outer catheter found pulled out at the guide wire hub.No other specific anomalies noted to the device.No functional evaluation performed due the nature and the condition of the device returned.One photo was provided and reviewed.The photo shows the guide wire hub noted detached form the catheter.No other anomalies noted.Therefore, based on the photo review, the reported detachment of device can be confirmed.Therefore, the investigation has confirmed for the reported detachment of device as the guide wire hub found detached to the device which returned for evaluation.A definitive root cause for the detachment of device could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 01/2023), g3 h11: h6 (method, 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.See h10.
Event or Problem Description
It was reported that during an angioplasty procedure, the hub of the guidewire allegedly detached after the first inflation attempt.It was further reported that another balloon was used to complete the procedure.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
• MDR Report Key: 11259020
• Report Number: 2020394-2021-00092
• Device Sequence Number: 4078802
• Product Code: LIT
• UDI-Device Identifier: 00801741058981
• UDI-Public: (01)00801741058981
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: DR8074
• Device Catalogue Number: DR8074
• Device Lot Number: 93NE0092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other