MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,100% SIL,COUDE,16FR 10ML

Catalog Number	DYND11592
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that while trying to remove the coude catheter prior to a transurethral resection of the prostate (turp) procedure, fluid was unable to be aspirated from the inflation port to deflate the catheter balloon.Reportedly, the hub of the inflation port was then cut off and a guidewire was passed through the inflation lumen by the physician in an attempt to deflate the catheter balloon but this was not successful.The physician then inserted a semi-rigid ureteroscope into the penis and passed it long the side of the coude catheter and the catheter balloon.The catheter balloon was able to be deflated upon passing it with the ureteroscope and the coude catheter was removed without further reported incident.There was no reported impact to the patient's stability or to the turp procedure.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the need for medical intervention to deflate the coude catheter's balloon, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the coude catheter's balloon would not deflate during removal.

• Common Device Name: CATHETER,FOLEY,100% SIL,COUDE,16FR 10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8451524
• Report Number: 1417592-2019-00037
• Device Sequence Number: 344478
• Product Code: EZL
• UDI-Device Identifier: 10884389124017
• UDI-Public: 10884389124017
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYND11592
• Device Lot Number: 592180707
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR