FDA Adverse Event Injury Summary report: N

PERMACATH 36 CM INTRAVENOUS DIALYSIS CATHETER

MDR report key: 660 · Received May 29, 1992

Report

Report Number
660
Event Type
Injury
Date Received
May 29, 1992
Date of Event
May 11, 1992
Report Date
May 13, 1992
Manufacturer
QUINTON
Product Code
FKO
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

DURING THE INSERTION OF A RIGHT SUBCLAVIAN PERMA-CATH DIALYSIS CATHETER, A J WIRE (GUIDEWIRE) WAS INSERTED INTO THE SUPERIOR VENA CAVA. THE DILATOR & SHEATH WERE PASSED OVER THE J WIRE WITH SOME DIFFICULTIES ENCOUNTERED, REQUIRING REMOVAL OF THE J WIRE AND REINSERTION OF THE NEEDLE OVER THE CUTOFF PORTION OF THE J WIRE. A NEW J WIRE WAS INSERTED & REAPPLICATION OF DILATOR & SHEATH WAS ACHEIVED. THE INSERTION OF THE PERMA-CATH CATHETER WAS COMPLETED BUT UPON REMOVAL OF THE J-WIRE SIGNIFICANT RESISTANCE WAS ENCOUNTERED. X-RAY REVEALED GOOD POSITION OF THE PERMA-CATH CATHETER BUT A PORTION OF THE J WIRE WAS LODGED IN THE SUPERIOR VENA CAVA AND EXTENDED INTO THE JUGULAR VEIN. PATIENT WAS TRANSFERRED TO OHSU/INTERVENTIONAL RADIOLOGY SAME DAY FOR SUCCESSFUL RETRIEVAL OF J WIRE IN TOTAL. RETURNED TO AGH SAME DAYDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER, OTHER, INVALID DATA. RESULTS OF EVALUATION: UNANTICIPATED SHORT TERM COMPLICATION OF PROCEDURE. CONCLUSION: THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE DISCARDED, OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PERMACATH 36 CM INTRAVENOUS DIALYSIS CATHETER Implant INTRAVENOUS DIALYSIS CATHETER FKO QUINTON 17748-001 409287

Patients

Seq Age Sex Outcome Treatment
1 73 YR Required Intervention