MAUDE Adverse Event Report: HOLLISTER INCORPORATED APOGEE IC; Catheter, Urethral

Model Number	10810
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an end user who uses the apogee intermittent catheter to irrigate his malone appendicostomy stoma, had the catheter migrate into his colon and required a colonoscopy to retrieve.It was reported that the end user inserted the catheter into the stoma and taped it to his skin.About two hours later, he went to flush saline through the catheter but found only the blue funnel present.It was reported that the catheter body migrated into the stoma during the two hours it was taped to his body.It was reported that despite numerous irrigations with the apogee intermittent catheter over the next several days, the catheter body would not come out rectally.It was reported that 5 days after this reported catheter migration, he had a colonoscopy performed rectally and the catheter was located and retrieved.It was reported that the end user felt fine after this procedure.
Additional Manufacturer Narrative
Representative samples from the same lot were tested in the plant and passed all testing.The dhr review was completed and no issues identified.The apogee intermittent catheters are intended to drain urine from the bladder.The use of this urethral catheter to irrigate a stoma is an indication not in the approved or cleared labeling for this product.Hollister is not aware of any other reports of use of the catheter for this application.No complaints have been received for the funnel separating from the catheter for this product over the last 3 years.

• Brand Name: APOGEE IC
• Common Device Name: Catheter, Urethral
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. IL 60048
• Manufacturer (Section G): HOLLISTER INCORPORATED; plot no. 27, sector-v; hsiidc growth centre; bawal, haryana 12350 1; IN 123501
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville. 60048 ; 8479321271
• MDR Report Key: 20651486
• Report Number: 3008191244-2024-00002
• Device Sequence Number: 6681876
• Product Code: GBM
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K992137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: Lay User/Patient
• Device Expiration Date: 07/01/2025
• Device Model Number: 10810
• Device Catalogue Number: 10810
• Device Lot Number: 2G256
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/05/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• 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: 26 YR
• Patient Sex: Male