MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number	AA61181002
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number: 79119602.
Event or Problem Description
Description: (b)(6).Impossibilité d'enlever la sonde urinaire dans le service d'urologie.Le cathéter a dû être retiré au bloc sous anesthésie générale.Douleurs importantes pour le patient, mobilisation des équipes chirurgicales et radiologiques.Translation of description of the incident by the customer: impossibility to withdraw the urinary catheter in the urology department.The catheter had to be removed in an operating room under general anesthesia.The patient felt significant pain, mobilization of surgical and radiological teams.
Additional Manufacturer Narrative
The returned product was inflated with a syringe and needle, without abnormality.The balloon had a slow deflation.During testing, a cut was made in the balloon.Visual examination revealed the eye of the tube was obstructed and was not open enough.The eye was obstructed by silicone material preventing deflation, coupled with obstruction by a pink powder of unknown origin.The investigation found that the issue likely occurred during the manufacturing process.
Event or Problem Description
Additional information received further reported that the patient did not have an underlying pathology.The patient was treated with an anti-inflammatory.The balloon had been inflated with 15cc water ppl.The ¿inflate way¿ was not obstructed by incrustations.The catheter was not folded.The surgical intervention included unblocking by rinsing the inflate lumen, pierced with a needle.A cystoscopy was not performed.The evolution of the patient was ¿good¿.

• Brand Name: FOLYSIL CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 12443076
• Report Number: 9610711-2021-00068
• Device Sequence Number: 3581689
• Product Code: EZL
• UDI-Device Identifier: 03600040127605
• UDI-Public: 03600040127605
• Combination Product (Y/N): N
• 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): 10/27/2021

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 Model Number: AA61181002
• Device Catalogue Number: AA6118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 88