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

Model Number	BD-410X-1855
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
Balloon would not deflate completely and got stuck trying to remove from the scope.The balloon then broke on the sheath.The issue occurred during a therapeutic procedure.The same device was used to complete the procedure.There was no patient harm or impact reported.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to inform that upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: EZDILATE BALLOON DILATOR (WG) 16-17-18
• Common Device Name: EZDILA BALLOON DILATOR (WG) 16-17-18
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11528216
• Report Number: 3003790304-2021-00052
• Device Sequence Number: 3764239
• Product Code: KNQ
• UDI-Device Identifier: 00821925033269
• UDI-Public: 00821925033269
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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 Model Number: BD-410X-1855
• Device Catalogue Number: BD-410X-1855
• Device Lot Number: 528019J
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1