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

Catalog Number	AA6418
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 was difficult to inflate and deflate.During the inflation test before device placement, it was difficult to inject and remove water from the balloon.No other adverse patient effects were reported.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint regarding the lot number 9018807.In september, we received one used sample.After desinfection it was observed that the balloon was assymetric and blocked the way to inflate/deflate and caused the issue observed.Our subcontractor investigation concluded on raw material issue on balloons conducting to assymetry.Checking the quality databases revealed one corrective and preventive action are ongoing: monitoring capa-000152: "balloon issues on folysil and silicone prostatic catheters".The trending on balloon asymetry issue is followed and below the threshold.
Event or Problem Description
According to available information, this device was difficult to inflate and deflate.During the inflation test before device placement, it was difficult to inject and remove water from the balloon.No other adverse patient effects were reported.

• 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: 17874035
• Report Number: 9610711-2023-00207
• Device Sequence Number: 4320947
• Product Code: EZL
• UDI-Device Identifier: 03600040130087
• UDI-Public: 3600040130087
• 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): 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: AA6418
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 04/19/2024
• 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
• Patient Sex: Unknown