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

Model Number	DR135610
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the two complaints, one sample is returned for evaluation and the second sample is not being returned for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model dr135610.Pta balloon dilatation catheter allegedly experienced a break.These reports were received from various sources.Of the two events, both involved patients with no reported patient injury.Age, weight, and gender were not provided for both patients.
Additional Manufacturer Narrative
H10: two device were returned for evaluation.The investigation for both devices identified a circumferential break at the glue joint.A root cause has not been determined.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.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model dr135610.Pta balloon dilatation catheter allegedly experienced a break.These reports were received from various sources.Of the two events, both involved patients with no reported patient injury.Age, weight, and gender were not provided for both patients.

• 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: 8812450
• Report Number: 2020394-2019-01665
• Device Sequence Number: 2196653
• Product Code: DQY
• UDI-Device Identifier: 00801741058851
• UDI-Public: (01)00801741058851
• 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): 10/14/2019

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: DR135610
• Device Catalogue Number: DR135610
• Device Lot Number: 93UC0077, 93YC0135
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/14/2019
• Patient Sequence Number: 1