FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 2993993 · Received March 3, 2013

Report

Report Number: 2993993
Event Type: Injury
Date Received: March 3, 2013
Date of Event: January 4, 2013
Report Date: March 3, 2013
Manufacturer: CONCEPTUS, INC
Product Code: HET
Adverse Event: Yes
Product Problem: Yes
Report Source: User Facility report
Reporter Location: PA, US
Reporter Occupation: INVALID DATA

Narratives

Description of Event or Problem · 1

THE UTERUS WAS SOUNDED TO 7 CM AND THE CERVIX WAS THEN DILATED TO A NUMBER 6 HEGAR ALLOWING THE OPERATIVE HYSTEROSCOPE TO BE PLACED. THIS WAS DONE WITHOUT TRAUMA OR DIFFICULTY. BOTH TUBAL OSTIA WERE READILY IDENTIFIED AND THE ESSURE WAS OPENED. THE ESSURE CATHETER WAS INTRODUCED. AN ATTEMPT AT CANNULIZATION OF THE LEFT TUBAL OSTIA WAS DONE AND THE CATHETER WAS INTRODUCED, HOWEVER APPROXIMATELY 2 MM INTO THE TUBAL OSTIA THE CATHETER DID NOT THREAD AND IN THE ATTEMPT TO BRING THIS BACK THE DISTAL PORTION OF THE COIL DETACHED AND WAS UNABLE TO BE BROUGHT OUT. THE REMAINING METAL INTRODUCER CATHETER AND CORNUA WERE ALL REMOVED. HOWEVER IT WAS FELT THAT DUE TO THE DEPTH OF PENETRATION INTO THE LEFT TUBAL OSTIA THAT ANY FURTHER ATTEMPTS TO REMOVE THIS WOULD RESULT IN BLEEDING OR FURTHER COMPLICATIONS OF PERFORATION. AN ATTEMPT WAS THEN PLACED ON THE RIGHT SIDE WITH A NEW CATHETER, HOWEVER THIS DID NOT PASS EASILY IN SPITE OF ALL ATTEMPTS AND ADMINISTERING OF TORADOL FOR TUBAL SPASM. THIS PORTION OF THE CASE WAS THEN ABANDONED AS WELL AND DUE TO THE INABILITY FROM AN ANATOMICAL STANDPOINT TO CATHETERIZE EITHER TUBAL OSTIA THE PROCEDURE WAS THEN ABANDONED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ESSURE CANNULATION STERILIZATION PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
90567	ESSURE	INSERT, TUBAL OCCLUSION	HET	CONCEPTUS, INC	ESS305	AA45117

Patients

Seq	Age	Sex	Outcome	Treatment
1	39 YR		Hospitalization\| R	NO OTHER THERAPIES