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

Model Number	AA63141002
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
According to available information, this device required replacement due to not filling.The device was checked after 2 hours and no urine had collected in the bag.The device was not able to be unblocked.The patient had a pelvic ultrasound and a bladder globe was found.During replacement it was found that the distal lumen had not completely punctured.No other adverse patient effects were reported.
Additional Manufacturer Narrative
The review of the complaint history database, revealed no trends for the lot number 8911274.The product reference (b)(4) lot number 8911274 has been manufactured for (b)(4) pieces in december 2022.The expiry date is december 2027.This product was made with the intermediate (b)(4) "im-folysil tiem im 5/15ml " lot number 8546589.This intermediate (b)(4) as been manufactured for 1861 pieces in november 2022.Checking the quality database revealed no anomaly in relation with the described product.A similar case study was done, same item number defect : drainage issue over last four years: no similary case was found.On 24th march we received, one used sample.After disinfection with anioxide 1000 catheter was tested: - inflation and deflation functionality is conformed - drainage functionality was tested: no drainage occured.A guidewire were passed inside catheter to define were it's blocked.Junction between distal tip and catheter tube was obstructed.The clinical assesment concluded: folysil catheter must only be used by trained and experienced professionals.The incident described as ¿catheter does not drain¿ happening few hours after traumatic catheterization, which may be due to a product defect (drainage lumen blocked), with clinical consequence as urinary retention may represent a clinical risk rated severity parameter level 3 related to risk of pain, urethral lesion and bleeding, urinary retention, and reintervention for change of device, referring to our clinical risk management procedure (b)(4).

• Brand Name: FOLYSIL CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• 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: 16627259
• Report Number: 9610711-2023-00046
• Device Sequence Number: 12093244
• Product Code: EZL
• UDI-Device Identifier: 03600040128640
• UDI-Public: 03600040128640
• 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): 05/18/2023

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
• Operator of Device: Health Professional
• Device Model Number: AA63141002
• Device Catalogue Number: AA6314
• Device Lot Number: 8911274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown