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
A manufacturing review was performed.The 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.Investigation summary: the device was returned for evaluation.An inflation attempt was made and a leak was noted at the butt joint between the catheter shaft and balloon.Upon closer examination, a partial break at the butt was noted.Therefore, the investigation is confirmed for the reported leak, as well as for a break at the butt joint.The partial break at the glue butt 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.Labeling review:the current ifu (instructions for use) states: warnings: if resistance is met during manipulation, determine the cause of the resistance before proceeding.Applying excessive force to the catheter can result in tip breakage or balloon separation.Use of the dorado pta dilatation catheter: advance the catheter through the introducer sheath and over the wire to the site of inflation.If the stenosis cannot be crossed with the desired dilatation catheter, use a smaller diameter catheter to pre-dilate the lesion to facilitate passage of a more appropriately sized dilatation catheter.Position the balloon relative to the lesion to be dilated, ensure the guidewire is in place and inflate the balloon to the appropriate pressure.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 during an angioplasty procedure in the sfa, contrast medium was allegedly leaking at the glue joint of the balloon catheter at 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: 7375087
• Report Number: 2020394-2018-00286
• Device Sequence Number: 1556678
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2018

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 Expiration Date: 08/11/2020
• Device Catalogue Number: DR8064
• Device Lot Number: 93VB0077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1