MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PERMCATH; ACCESSORIES, A-V SHUNT

Model Number	8888169001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, 2 years after implantation, the catheter was too floppy and it was very difficult to remove, the cuff was stuck.To avoid the catheter breaking off in the patient, a small incision was made and the cuff was slowly dissected away from the chest wall.A slight tear can be noted on the catheter at the cuff which would have broken off.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, 2 years after implantation, the catheter was too floppy and it was very difficult to remove, the cuff was stuck.To avoid the catheter breaking off in the patient, a small incision was made and the cuff was slowly dissected away from the chest wall.No excessive force used in taking out the catheter but with just a more complicated removal with larger incision using a standard minor tray with scalpel.They normally do not take out under fluoroscopy but they had to with this patient.Chloraprep or chlorhexidine was the cleaning agent used on the device.The catheter was removed on the day of the event because the patient no longer required dialysis therapy.A slight tear can be noted on the catheter at the cuff which would have broken off.The catheter was not repaired or replaced.The patient had no harm and went home right after.

• Brand Name: PERMCATH
• Common Device Name: ACCESSORIES, A-V SHUNT
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 12308096
• Report Number: 3009211636-2021-00207
• Device Sequence Number: 3209898
• Product Code: KNZ
• UDI-Device Identifier: 10884521009929
• UDI-Public: 10884521009929
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K840424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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: 8888169001
• Device Catalogue Number: 8888169001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 08/30/2021
• 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