MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL SILICONE CATHETER - LONG-TERM; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

Catalog Number AA7108

Device Problems Fracture (1260); Nonstandard Device (1420)

Patient Problem Urinary Retention (2119)

Event Date 11/28/2023

Event Type  Injury  

Event Description

According to the available information the patient was a young toddler who underwent surgery for a spinal cord defect.Prior to surgery his parents were undertaking cic.Post-operatively there were some changes in his bladder function and at one point there was an attempt to insert a coloplast indwelling catheter.The catheter was inserted with relative ease.There was some initial resistance but the catheter advanced, sadly no urine was drained; therefore, the balloon was not inflated, the catheter was removed.On removal the tip was noted to be missing.Renal ultrasound was unable to detect any foreign body and to date the tip has not been passed ureterally.The patient has been seen by our in-house surgical team and his case discussed with the specialist pediatric urology team at (b)(6) hospital.

Manufacturer Narrative

After receiving this complaint, we searched for other complaints and we found none regarding the lot number 8062919.No sample available but on the pictures provided, coloplast notes that the tip is missing.Analysis of the quality database revealed one change control, for the addition of longitudinal precuts, which can be potentially related to this issue.Since implantation of the change control in 2014, it is strongly recommended to use longitudinal precuts to avoid the tip detachment.Transversal precut is not recommended and should be used with great caution.Similar case study was performed based on same item number and same defect [tip missing] from december 2019 to december 2023: no similar case was found.A risk management framework evaluation was performed and concluded that the residual risks are adequately controlled and reduced as far as possible, and the residual risks associated with the use of the product are acceptable when weighed against the benefits to the patient/user.It is concluded that the risks identified are still acceptable and considered as safe.Causality assessment- the incident described as catheter¿s tip retained in the bladder is related to the device.

• Brand Name: FOLYSIL SILICONE CATHETER - LONG-TERM
• Type of Device: INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): CMF-SARLAT; 9 avenue edmond rostand; sarlat-la-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18393319
• MDR Text Key: 331315716
• Report Number: 9610711-2023-00287
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040132562
• UDI-Public: 3600040132562
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AA7108
• Device Lot Number: 8062919_AA71081002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other