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

Catalog Number	DR8064
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that post covered stent (other manufacturer) placement in the superficial femoral artery (sfa), contrast medium allegedly leaked at the glue joint between the catheter shaft and the balloon when the balloon was inflated to approximately 20 atm.There was no reported patient injury.
Additional Manufacturer Narrative
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.This is the only complaint reported to date for this lot number and failure mode.The device was returned for evaluation.The device was inflated and water was seen exiting the device at the glue joint at the proximal end of the balloon.The glue joint was examined under magnification and a partial break was noted.Therefore, the investigation is confirmed for the reported leak as well as for a break at the glue joint.The partial break at the glue joint resulted in the identified leak.However, the definitive root cause for the partial break could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(b)(4).
Event or Problem Description
It was reported that post covered stent (other manufacturer) placement in the superficial femoral artery (sfa), contrast medium allegedly leaked at the glue joint between the catheter shaft and the balloon when the balloon was inflated to approximately 20 atm.There was no reported patient injury.

• Brand Name: DORADO PTA BALLOON DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens TX 75751
• MDR Report Key: 7375085
• Report Number: 2020394-2018-00285
• Device Sequence Number: 13726138
• Product Code: DQY
• 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): 04/20/2018

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 Catalogue Number: DR8064
• Device Lot Number: 93VB0077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1