MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; 1LYRTR 16FR10ML100% SILTMP SNP

Catalog Number	DYND11532H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6), the patient was having a catheter inserted at the time of the balloon popping.The catheter was removed and was replaced the next day.
Additional Manufacturer Narrative
According to the facility on (b)(6), the patient was having a catheter inserted at the time of the balloon popping.The catheter was removed and was replaced the next day.No injuries are identified at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.
Additional Manufacturer Narrative
Update to d4.After further investigation, it has been determined that the catalog number of the product is dynd11532h.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: 1LYRTR 16FR10ML100% SILTMP SNP
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21754844
• Report Number: 1417592-2025-00156
• Device Sequence Number: 18553721
• Product Code: EZL
• UDI-Device Identifier: 10193489988505
• UDI-Public: 10193489988505
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 09/03/2025

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?: No
• Device Catalogue Number: DYND11532H
• Device Lot Number: 59224030737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 09/03/2025
• 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: 89 YR
• Patient Sex: Female
• Patient Weight: 63 KG