MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE BALLOON DILATOR (WG) 16-17-18

Model Number BD-410X-1855

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2024

Event Type  malfunction  

Event Description

It was reported, the ezdilate balloon dilator (wg) 16-17-18 was filled up the first time and it fulfilled its function.When the balloon was refilled, it was leaking.The issue occurred during an endoscopic retrograde cholangiopacification (ercp) procedure.The procedure was completed using a similar device.There were no reports of patient harm.

Manufacturer Narrative

The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EZDILATE BALLOON DILATOR (WG) 16-17-18
• Type of Device: EZDILATE BALLOON DILATOR (WG) 16-17-18
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18959690
• MDR Text Key: 338366242
• Report Number: 3011050570-2024-00112
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 00821925033269
• UDI-Public: 00821925033269
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K180086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BD-410X-1855
• Device Lot Number: 409212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1