MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; 1LYR 16FR10ML 100%SIL TMP SAFE

Catalog Number URO170816TQ

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient was undergoing a urolift procedure and the balloon of the catheter popped inside of the patient.According to the facility the balloon was inflated with the prefilled 10cc saline syringe.The facility reported that they used three catheters and experienced the same issue with all three catheters however feel it may be due to the urolift procedure and not the product.No sample was returned for evaluation.No additional information was provided.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a patient was undergoing a urolift procedure and the balloon of the catheter popped inside of the patient.

• Type of Device: 1LYR 16FR10ML 100%SIL TMP SAFE
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13281211
• MDR Text Key: 284004268
• Report Number: 1417592-2022-00004
• Device Sequence Number: 1
• Product Code: OHR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: URO170816TQ
• Device Lot Number: 21HBR854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other