MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DBD-1LYR SILI-ELA LTX 16FR 10ML COUDE TR

Catalog Number	DYND160116C
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Balloon became deflated while in use.
Additional Manufacturer Narrative
It was reported that the patient was experiencing pain.Due to this, he visited the emergency room.The catheter balloon was deflated, advanced, and reinflated to 10cc with sterile water.Patient stated it felt better.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: DBD-1LYR SILI-ELA LTX 16FR 10ML COUDE TR
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23745021
• Report Number: 1417592-2025-00688
• Device Sequence Number: 21041586
• Product Code: OHR
• UDI-Device Identifier: 10884389118757
• UDI-Public: 10884389118757
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYND160116C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 90 KG