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); Retraction Problem (1536); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
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 not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 09/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly separated from the shaft of the catheter and could not be removed from the sheath.It was further reported that the entire sheath and balloon were taken out together and a new sheath was inserted.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the device allegedly had a break at the proximal balloon joint.It was further reported that the shaft of the catheter could not be removed from the sheath.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 that the device appeared bloody and the guide wire lumen was exposed.The device also had a break at the proximal balloon joint and the balloon has been covered by the sheath.The second photo shows that the device was bloody and the sheath has been removed from the balloon.The device had a break at the proximal balloon joint and the guide wire lumen was exposed.Therefore, based on the photo review, the reported break and retraction problem can be confirmed.Therefore the investigation reported for the catheter break was confirmed as the device had a break at the proximal balloon joint.The investigation reported for the retraction problem was also confirmed from the submitted photo that the inner guidewire lumen was pulled out from the catheter during the withdrawal.The retraction issue is likely the root cause for the proximal balloon joint break.However, the definitive root cause for the retraction issue 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.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.

• 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: 11670371
• Report Number: 2020394-2021-00859
• Device Sequence Number: 19622135
• Product Code: LIT
• UDI-Device Identifier: 00801741059544
• UDI-Public: (01)00801741059544
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K072283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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: 93WE0075
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 06/04/2021
• 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