MAUDE Adverse Event Report: CONMED CORPORATION 20MM ELIMINATOR PET ESOPHAGEAL BALLOON DILATOR ADVANTAGE PACK; DILATOR, ESOPHAGEAL

Catalog Number 000379

Device Problems Retraction Problem (1536); Failure to Eject (4010); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

At time of filing, the reported device is not expected to be returned to conmed for evaluation.This reported event is entering the investigation process.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the facility, the conmed sales representative reported an issue with the 20mm eliminator pet esophageal balloon advantage pack, item 000379, lot 201904221, that occurred (b)(6) 2019 during an egd procedure.It was reported only that the balloon did not deflate.Additional information received indicates that the patient was sedated when the issue was noted.The balloon was inserted through the scope with no problem noted.The balloon was filled with saline and already in place.A stopcock was used with the balloon device and either a gifq or gifh scope was used with the device as that is what the facility reports using for all egd procedures.The m00550620 alliance ii inflation/litho device was used for both inflation and attempted deflation of the eliminator pet esophageal balloon.The esophageal balloon didn't deflate using the m00550620 alliance ii inflation/litho device and would not deflate when the nurse tried to use a syringe.The scope had to be removed with the balloon still inflated.Once removed from the patient, the balloon was cut to be able to remove it from the scope.It is noted that there was no lasting impact or injury to the patient, however, the patient required more sedation, and had to be re-intubated after the balloon was removed so that the doctor could take biopsies.There was no other additional medical/surgical intervention required for the patient due to these issues.The procedure was successfully completed with a delay of unreported length.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The investigation of the reported complaint is inconclusive.The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified, root cause could not be identified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue.A two-year lot history review was conducted and found no other similar complaints for this lot number and failure mode.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.The ifu also advises the user that prior to deflation, to verify the entire length of the inflated balloon dilator is extended beyond the distal opening of the endoscope prior to deflation.Withdraw all fluid from the dilator.For deflation using the conmed inflation device, attach the inflation system to the proximal end of the balloon dilator catheter and turn the handle counter-clockwise until zero (0) pressure is reached.Release the lock lever and pull the syringe handle back.For syringe deflation, attach a 60cc (ml) syringe to the proximal end of the balloon dilator catheter and open the stopcock.Apply and maintain negative pressure by pulling the syringe handle back.For full deflation maintain negative pressure for approximately 60 seconds.With the distal end of the endoscope straightened, apply firm continuous force to withdraw the balloon dilator from the endoscope.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 20MM ELIMINATOR PET ESOPHAGEAL BALLOON DILATOR ADVANTAGE PACK
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 9007644
• MDR Text Key: 158992418
• Report Number: 1320894-2019-00332
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: K033936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2021
• Device Catalogue Number: 000379
• Device Lot Number: 201904221
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 09/13/2019
• Supplement Dates FDA Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1