MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; 1LYRTR 16FR10ML100%SILI UMSNAP

Catalog Number	URO175816
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, "the patient had a foley inserted by urologist for a robotic prostatectomy.The balloon needs to be deflated mid-surgery for removal after prostate is excised.".
Additional Manufacturer Narrative
According to the customer, "the patient had a foley inserted by urologist for a robotic prostatectomy.The balloon needs to be deflated mid-surgery for removal after prostate is excised.Rnfa at sterile field could not get the foley to deflate-syringe would not draw back.Then they cut the foley (across both channels) and the balloon still did not deflate.The surgeon injected mineral oil to pop balloon and foley was able to be removed.There was no injury/issues".A sample is not available for evaluation.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.

• Common Device Name: 1LYRTR 16FR10ML100%SILI UMSNAP
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 19733660
• Report Number: 1417592-2024-00736
• Device Sequence Number: 17921543
• Product Code: PPB
• UDI-Device Identifier: 40193489987462
• UDI-Public: 40193489987462
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/12/2024

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: URO175816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 07/12/2024
• 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 Sex: Unknown