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

Model Number	DR8064
Medical Device Problem Codes	Break (1069); Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
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 sample was returned to the manufacturer for inspection/evaluation.The investigation of the reported event is currently underway.(expiry date: 07/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon would not remain inflated and allegedly ruptured at 12atm.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon would not remain inflated and allegedly ruptured at 12atm.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 dilatation catheter has been returned for the evaluation.On the visual evaluation, the device appeared bloody.No kinks noted to the catheter, no other specific anomalies were noted.On the functional evaluation of the device , the guidewire lumen of the catheter was flushed using an in-house syringe and the water was able to successfully exit out of the distal tip but noted to be bloody.On further the balloon was inflated using in-house presto inflation device and then the water starts leaking from the proximal glue joint of the balloon.Under microscopic observation circumferential break was noted at the proximal glue joint.Therefore the investigation for the reported inflation issue was confirmed as the water leaks from the circumferential break at proximal glue joint and thus the balloon fails to maintain the uniform shape and pressure.The investigation for the reported balloon rupture has been inconclusive as the balloon was unable to fully inflated due to the break at the proximal glue joint.The investigation for the identified break has been confirmed as the water starts leaking from the break at the proximal glue joint of the balloon and it was also examined under the microscope.A definitive root cause for the reported balloon rupture, inflation issue and the identified break 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: 07/2023), h11: h6(result, conclusion), 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.

• 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: 11743594
• Report Number: 2020394-2021-00940
• Device Sequence Number: 19890187
• Product Code: LIT
• UDI-Device Identifier: 00801741058721
• UDI-Public: (01)00801741058721
• 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): 06/30/2021

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: DR8064
• Device Catalogue Number: DR8064
• Device Lot Number: 93UE0078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 04/03/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 07/07/2021
• 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