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

Model Number	DR13564
Medical Device Problem Codes	Break (1069); Material Rupture (1546); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
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: 03/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one dorado pta catheter has returned for evaluation.On the visual evaluation the device it appears bloody, no specific anomalies noted.On the functional evaluation device, the guide wire lumen was flushed, and in-house guide wire was attempts to advance through the catheter from the distal tip, a resistance was felt as advance, and blood was expel from the guide wire luer as the guidewire further advance.The guide wire was not successfully advanced.On further the device was inflated with in-house presto device and the balloon inflated at 8 atm and then 24 atm, it could be able to maintain shape and pressure.The balloon was deflated, and it was noted blood was suctioned back into the presto inflation device from within the balloon.A second attempt to inflate the balloon was conducted, this time with the gw removed.The balloon was inflated, and water exited from the proximal glue joint.Increasing the pressure caused more water to leak and no pressure was held in the inflation device.No evidence of balloon rupture.Microscopic observation was performed partial circumferential break was noted on the proximal glue joint.Therefore, the investigation for the reported balloon rupture has unconfirmed as no balloon rupture noted on the functional evaluation of returned device.The investigation has confirmed for identified break as water leaks from partial circumferential break on the proximal glue joint during the evaluation.The investigation has confirmed for the identified device-device incompatibly has the guide wire was not able advance into the catheter during the evaluation testing.A definitive root cause for the alleged balloon rupture and identified break and device-device incompatibility 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: (expiry date: 03/2023).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.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured.It was further reported that 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
• MDR Report Key: 11291687
• Report Number: 2020394-2021-00161
• Device Sequence Number: 3440130
• Product Code: LIT
• UDI-Device Identifier: 00801741058745
• UDI-Public: (01)00801741058745
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 05/20/2021

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: DR13564
• Device Catalogue Number: DR13564
• Device Lot Number: 93QE0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 06/24/2021
• 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