MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PERITONEAL DIALYSIS CATHETER.; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Catalog Number	CF-5260/C
Medical Device Problem Codes	Obstruction of Flow (2423); Defective Device (2588); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that an 82-year-old male patient presented in a wheelchair conscious and oriented.The functionality of the catheter was evaluated.An abdominal x-ray was performed showing the catheter had migrated outside the pelvic cavity.Out of position.The drainage catheter was tested, and it was found that the pd catheter was occluded and would not drain.The physician ordered the pd catheter replacement.The patient tolerated the procedure well.There were no additional patient consequences to report.
Additional Manufacturer Narrative
The suspect medical device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.

• Brand Name: PERITONEAL DIALYSIS CATHETER.
• Common Device Name: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer Contact: bryson heaton rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 20261108
• Report Number: 1721504-2024-00067
• Device Sequence Number: 8207425
• Product Code: FJS
• UDI-Device Identifier: 00884450330166
• UDI-Public: 884450330166
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K970159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: CF-5260/C
• Device Lot Number: H2891847
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2024
• 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 Age: 82 YR
• Patient Sex: Male