MAUDE Adverse Event Report: COLOPLAST A/S BIOSOFT DUO DOUBLE LOOP STENT; URETERAL STENT

Model Number BCAJ851002

Device Problem Material Too Soft/Flexible (4007)

Patient Problem Kidney Infection (4502)

Event Date 02/03/2023

Event Type  Injury  

Event Description

According to available information, this device was not able to be placed due to softness.The device could not move along the guidewire and curled up on itself like an accordion.It was reported the device was too soft.No other adverse patient effects were reported.

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.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Manufacturer Narrative

The review of the complaint history database, revealed no trends for the lot number 8324239.The product reference (b)(4) lot number 8324239 has been manufactured for 15 pieces in november 2021.The expiry date is january 2023.Checking the quality database revealed no anomaly in relation with the described product.A similar case study was done concerning same item number, same defect, incidence yes over last four years: no similar case was found.Sample received was observed and we saw the stent was curled.Functionality of this stent was tested.Terumo guidewire was wet into the dispenser and then stent was positioned on guidewire.No difficulty was observed during positioning or removed the stent on the guidewire.No issue was observed.Despite sample investigation, we cannot define precisely one root cause.We can suppose that the guidewire are start drying during positioning of the second jj stent.In this case ifu advises: " if the guide wire m non-vascular sticks into the working channel of theendoscope, or during device insertion, or prior to reinsert the guide wire m non-vascular into the same patient during the same procedure, the guide wire should be wetted by wiping it once with a gauze moistened with physiological saline solution." rmf evaluation was done based on criq246 risk no.11313, 11314 concerning hazardous situation "sock" effect during jj insertion were identified.The evaluation has showed that risks are adequately controlled and reduced as far as possible in the state of art.Based on this, we can conclude 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.

• Brand Name: BIOSOFT DUO DOUBLE LOOP STENT
• Type of Device: URETERAL STENT
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16440555
• MDR Text Key: 310225185
• Report Number: 9610711-2023-00024
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K170422
• 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: 05/17/2023

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 Expiration Date: 07/08/2023
• Device Model Number: BCAJ851002
• Device Catalogue Number: BCAJ85
• Device Lot Number: 8311802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2021
• 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): Required Intervention