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

Model Number	DR8088
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For both of the reported events, the devices were returned to bd and are being evaluated.As the company is still investigating the issue at this time, there are no conclusions currently available.''acrum''.
Event or Problem Description
This report summarizes two malfunction events.A review of the events indicated that model dr8088 dorado pta balloon dilatation catheter had issues retracting.These reports were received from various sources.In both events, the weight, age, and sex of each patient was not provided.The dr8088 dorado pta balloon dilatation catheter were returned the manufacturer and are pending investigation.
Additional Manufacturer Narrative
H10: the lot numbers for the two malfunction was provided and a lot history review will be performed.Of the two reported malfunctions, one device was returned for evaluation; the evaluation identified that the pta balloon dilatation catheter was inserted and retracted through a 6f introducer sheath with slight resistance at a noted kink but otherwise had no issue inserting/retracting through sheath.The other device was no returned; therefore, the investigation is inconclusive for the retraction problem as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause for the reported malfunctions is unknown.The devices are labeled for single use.H10: g4 h11: h6 (results, 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.
Event or Problem Description
This report summarizes two malfunction events.A review of the events indicated that model dr8088 dorado pta balloon dilatation catheter had issues retracting.These reports were received from various sources.In both events, the weight, age, and sex of each patient was not provided.

• Brand Name: DORADO PTA BALLOON 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: 8516204
• Report Number: 2020394-2019-00319
• Device Sequence Number: 1524977
• Product Code: DQY
• UDI-Device Identifier: 00801741059322
• UDI-Public: (01)00801741059322
• 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): 07/23/2019

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: DR8088
• Device Catalogue Number: DR8088
• Device Lot Number: 93XC0065
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1