MAUDE Adverse Event Report: CONMED CORPORATION 18MM X 8CM ESOPH BAL DIL; ELIMINATOR PET BALLOON DILATOR

Catalog Number 000345

Device Problem Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

The used device was returned to conmed for evaluation.Visual inspection found the device's detachable stopcock was not present, the balloon was observed to be pre-inflated and no non-conforming defects were found.Functional testing was performed and water was injected into the device's port with a conmed inflation device until pressure was measured on the inflation device pressure gauge.The inflation device's piston was then locked, and the handle was turned until the pressure measured approximately 25 psi.No fluctuations were observed during 2 minutes of observation.The inflation device's handle was approximately 50 psi, and no fluctuations in the pressure gauge were observed during 2 minutes of observation.No balloon defects were observed during visual and functional inspection.The reported device was found to perform as intended and to maintain stable pressure readings at pressures recommended by the complaint device's instructions for use.A review of the manufacturing documents has verified the devices were produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture.A historical review of complaint data revealed no prior complaints for this device and failure mode.In that same time frame, (b)(4).Risk assessment found this failure mode and occurrence level to be consistent with current risk documents.The instructions for use advise the user of the following.- for inflation using the conmed inflation device, orient the inflation device in a downward position such that any air remains within the syringe when connected to the conmed eliminator 3-stage pet balloon dilator.Inflate by turning the handle clockwise until recommended pressure is achieved as specified for the selected size balloon as stated below.- for syringe inflation, the recommended syringe size for inflation is 20 cc (ml) for 6 mm/8 mm/12 mm, 30 cc (ml) for 15 mm/18 mm balloons and 40 cc (ml) for 20 mm balloons.- when the balloon dilator has reached maximum pressure the stopcock handle should be turned so that the pressure monitor is closed off to maintain balloon pressure.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The user facility reported that during an esophageal dilation procedure the pet balloon dilator was not holding pressure per the inflation device gauge while inflating the balloon.The balloon continued to fill with water, which caused it to overfill.The pet balloon was removed and the procedure was completed with a savory dilator.There was a 5-minute surgical delay.No patient injury reported.This report is raised on the basis of a reported malfunction with potential for injury with recurrence.

• Brand Name: 18MM X 8CM ESOPH BAL DIL
• Type of Device: ELIMINATOR PET BALLOON DILATOR
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: martha camacho urribarri ; 525 french road; utica, NY 13502-5994
• MDR Report Key: 6941883
• MDR Text Key: 90308599
• Report Number: 1320894-2017-00213
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 20653405052460
• UDI-Public: (01)20653405052460(17)190724(10)201707241
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2019
• Device Catalogue Number: 000345
• Device Lot Number: 201707241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1