MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number	AA61081002
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.
Event or Problem Description
According to the available information, the surgeon placed a bladder stent without any noticeable issues during an appendectomy of a young patient.Post operatively, the stent was left in place.Fifteen minutes after the patient arrived in the recovery room, the surgeon was called back because the stent was no longer in place.The stent was "cut in half" and the distal end remained in the bladder.The patient was placed under general anesthesia and a cystoscopy was performed to remove the distal end.There were no subsequent consequences.The balloon had not been inflated prior to installation.No sharp objects had been used.It was reported that probing mandrel in place, there was greater resistance than usual when withdrawing the mandrel.It was probable shear injury at this time; spontaneous rupture of the probe occurred approximately 30 minutes later.
Additional Manufacturer Narrative
A five-centimeter segment was received for analysis.In the absence of information about the device status before use, after the mandrel removal, and without the available entire device it is not possible to conclude on the root cause of this incident.

• Brand Name: FOLYSIL CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11120494
• Report Number: 9610711-2021-00005
• Device Sequence Number: 19814166
• Product Code: EZL
• UDI-Device Identifier: 03600040126974
• UDI-Public: 03600040126974
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2025
• Device Model Number: AA61081002
• Device Catalogue Number: AA6108
• Device Lot Number: 7504517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2020
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 08/09/2021
• 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: 7 YR