MAUDE Adverse Event Report: GYRUS ACMI, INC EZDILATE BALLOON DILATOR (FW) 18-19-20

Model Number BD-400P-2080

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2019

Event Type  malfunction  

Manufacturer Narrative

The referenced device was returned to the manufacturer and is pending evaluation.The cause of the reported event could not be determined at this time.However, if additional information becomes available at a later date, this report will be updated and a supplemented accordingly.

Event Description

The manufacturer was informed that during a diagnostic and therapeutic esophagogastroduodenoscopy (egd) procedure while inserting the balloon some resistance was met.The balloon was inflated once to it's full pressure and then deflated at the end of the case.The balloon would not retract out of the scope and had to be removed from the patient with the balloon still in the biopsy port of the scope.After removal, the catheter had to be cut to remove the balloon.The procedure was completed at that point, therefore, another balloon was not needed.There was no unexpected bleeding to the patient or patient injury reported.The balloon was inspected prior to use and no anomalies were noted.

Manufacturer Narrative

The product was returned and evaluated by the original equipment manufacturer (nordson medical).A dhr was reviewed and the oem noted that there were no abnormalities in the documentation or the manufacturing process were noted.All samples met specifications.The cause of the reported event could not be conclusively determined.Additionally, there have been 19 retrieval complaints in the past 12 months, but the cause of the events were not able to be confirmed.

Manufacturer Narrative

This supplemental report is being submitted to provide the physical evaluation results.The device was returned for evaluation for the reported "the balloon being unable to be removed from the scope".The device was received in its tyvek pouch with blue foam covering the sharp/broken ends of the device.The device was cut roughly 26.5" from the proximal end to remove it from the scope after removing it from the patient.Both the balloon and the luer appeared to be intact.The rest of the sheathing appeared to be intact as well.The investigation is ongoing as the device was sent to the oem for further investigation.If additional information becomes available, this report will be updated accordingly.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 18-19-20
• Type of Device: EZDILATE BALLOON DILATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8872257
• MDR Text Key: 155222885
• Report Number: 2951238-2019-01049
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT-KNQ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2019

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 Model Number: BD-400P-2080
• Device Lot Number: 509019A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: 07/24/2019; 10/28/2019
• Supplement Dates FDA Received: 08/16/2019; 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1