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

Catalog Number	DR8074
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2018
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 pending.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 a balloon was allegedly dilated from 4 atm to 20 atm to treat a thrombotic lesion.When the balloon was inflated to 20 atm the balloon allegedly ruptured.Reportedly, the health care provider used another balloon catheter to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: 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 labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Investigation review: the device was returned for evaluation.A visual inspection did not find any indications of balloon rupture.The device was inflated and water was seen exiting a partial break at the proximal balloon butt joint.Therefore, the investigation is confirmed for a break.However, when the balloon took its shape when partially inflated, no circumferential ruptures were noted.Therefore, the investigation is unconfirmed for the reported circumferential rupture.It is unknown if the identified leak was perceived as the reported circumferential rupture, while in the patient.However, the definitive root cause for the identified break or reported rupture could not be determined based on the available information.The complaint frequency analysis concluded that the complaint frequency is not increasing and the threshold has not been exceeded.The facts from the investigation (i.E., cfa output, similar complaints, previous investigation information, etc.) were entered into the corporate decision reference form (drf).Based on the drf, no additional action and/or corrective action are required at this time.
Event or Problem Description
It was reported that a balloon was allegedly dilated from 4 atm to 20 atm to treat a thrombotic lesion.When the balloon was inflated to 20 atm the balloon allegedly ruptured.Reportedly, the health care provider used another balloon catheter to complete the procedure.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: 7387376
• Report Number: 2020394-2018-00323
• Device Sequence Number: 1067851
• Product Code: DQY
• UDI-Device Identifier: 00801741058981
• UDI-Public: (01)00801741058981
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2018

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: DR8074
• Device Lot Number: 93LZ0043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 50