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

Catalog Number AA6106

Device Problem Failure to Deflate (4060)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2024

Event Type  Injury  

Event 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.

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.

• Brand Name: FOLYSIL SILICONE CATHETER
• 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: 18809123
• MDR Text Key: 336577598
• Report Number: 9610711-2024-00048
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• 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
• Report Date: 02/29/2024

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: AA6106
• Device Lot Number: 9445801_AA61061002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/29/2024
• Date Device Manufactured: 10/26/2023
• 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): Required Intervention