MAUDE Adverse Event Report: FUTUREMATRIX INTERVENTIONAL DORADO PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	DR8094
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One of the devices was returned for evaluation.The device was received in two segments.The detached balloon was stuck in a 6f sheath.It is unknown whether patient and/or procedural factors contributed to the event.Based on the available information, the definitive root cause is unknown.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 dr8094 pta balloon dilatation catheter allegedly was difficult to retract through the sheath and detached.The devices were used with the sheath as a single unit.There was no reported patient injury.One patient was an (b)(6)-year-old male who weighed (b)(6) kilograms.Age, weight, and gender for the other patient was not provided.

• Brand Name: DORADO PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens TX 75751
• MDR Report Key: 8817519
• Report Number: 2020394-2019-01759
• Device Sequence Number: 2484619
• Product Code: DQY
• UDI-Device Identifier: 00801741059445
• UDI-Public: (01)00801741059445
• 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
• 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: DR8094
• Device Catalogue Number: DR8094
• Device Lot Number: 93ZC0128
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1