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

Catalog Number AA7116

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/22/2023

Event Type  Injury  

Event Description

According to the available information the tip of the catheter remains in the patient.

Manufacturer Narrative

After receiving this complaint, we searched for other complaints and we found none regarding the lot number 9390324.Without the sample or picture we cannot do more than a documentary investigation and no anomaly was recorded during manufacturing process.Based on element known we cannot define potential root cause about this issue.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.Based on the investigation performed, checking the quality database revealed one change control cc (b)(4) "packaging - addition of longitunal precuts" opened on september 2013 and closed on january 2014 which can be potentially related to this issue.Since implantation of change control, 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.A risk management file evaluation was performed and concluded that 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.A clinical assessment was performed and the causality assessment concluded: the incident described as catheter¿s tip retained in the bladder is related to the device.Correction: e1 country.

• 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: 18553913
• MDR Text Key: 333380817
• Report Number: 9610711-2024-00022
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 05/28/2024

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: AA7116
• Device Lot Number: 9390324_AA71161002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2023
• 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