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 Code	Unintended Radiation Exposure (4565)
Date of Event	05/27/2021
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, blunt dissection was done to remove the catheter's cuff but it was unsuccessful after multiple attempts.The catheter was said to be very floppy and difficult to remove.The distal end of the catheter was inadvertently severed and the proximal end of the catheter was clamped with a hemostat.It was said that the patient was then transferred to the interventional radiology laboratory and the patient's neck and chest was then re-prepped in sterile fashion.Fluoroscopic imaging revealed a sheared though intact tunneled dialysis catheter.Next, small incision was made superior to the insertion site and by using a sharp and blunt dissection, the catheter was freed and subsequently removed.Manual pressure was held over the right internal jugular vein area until hemostasis was achieved.The small incision was closed with 3-0 vicryl suture.The patient left the interventional radiology laboratory in stable condition.

• 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: 12307872
• Report Number: 3009211636-2021-00206
• Device Sequence Number: 17088552
• Product Code: KNZ
• UDI-Device Identifier: 10884521009929
• UDI-Public: 10884521009929
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K840424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/11/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/11/2021
• 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