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

Catalog Number	AA6106
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information the balloon inflated to the volume indicated by the manufacturer.At examination in the hdj nephrocardio department, the nurse was unable to deflate the balloon to remove the catheter.Several attempts with 1ml, 2ml, 5ml and 10ml syringes.A new attempt to deflate the balloon with a syringe without success.The surgeon cut the catheter upstream of the balloon valve to irrigate the balloon, without success.Bladder ultrasound performed in emergency revealed the balloon was still in place.Decision to stay overnight with surgery the next day.Patient returned home the next day.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we found another complaint on the lot n° 9445801 (b)(4).The aa61061002 lot 9445801 has been packaged with intermediate products ref aa610680 lot 8992985 in october 2023 and the expiry date is october 2028.The aa610680 lot 8992985 has been manufactured by our tunisian site.(informed) checking the quality databases revealed a connection with the described defect with capa -000152.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we found one other complaint on the lot n° 9445801.We received one used sample which was not complete.Only the body part with balloon was received.The valve part of the device was not returned.As a result, the functionality of inflation/ deflation balloon without this part cannot be tested.Checking the quality databases revealed this type of defect is closely monitored.A similar case study was performed based on same item number and same defect over the last four years: 5 similar cases were found.Causality assessment: the incident described as catheter balloon deflation being impossible is related to the device.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.
Event or Problem Description
According to additional available information, the indication for catheterization was mag3 scintigraphy under catheterization.Urinary meatus was the chosen route of catheterization, and the balloon was not tested before insertion.

• Brand Name: FOLYSIL SILICONE CATHETER
• Common Device Name: 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: 18809123
• Report Number: 9610711-2024-00048
• Device Sequence Number: 7248277
• Product Code: EZL
• UDI-Device Identifier: 03600040126844
• UDI-Public: 3600040126844
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: AA6106
• Device Lot Number: 9445801_AA61061002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 MO
• Patient Sex: Unknown