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

Model Number	DR13554
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a lot history review was performed.The return of sample is pending.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model dr13554 pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The age, sex and weight of the patient were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model dr13554 pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The age, sex and weight of the patient were not provided.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.Therefore, the investigation is confirmed for the identified leak issue and torn inner lumen.However, the investigation is unconfirmed for the balloon rupture.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use 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.

• 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: 10291074
• Report Number: 2020394-2020-04622
• Device Sequence Number: 19407417
• Product Code: DQY
• UDI-Device Identifier: 00801741058516
• UDI-Public: (01)00801741058516
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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: No Information
• Device Model Number: DR13554
• Device Catalogue Number: DR13554
• Device Lot Number: 93PD0092
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 10/14/2020
• Patient Sequence Number: 1