WOMANCARE GLOBAL WAS NOTIFIED BY THE DISTRIBUTOR OF THE IPAS EASYGRIP CANNULAE IN (B)(4), THAT A SERIOUS ADVERSE EVENT OCCURRED IN A HOSPITAL IN (B)(6) ON (B)(6) 2013. THE DISTRIBUTOR COMMUNICATED THAT THE HOSP REPORTED THAT WHILE A PHYSICIAN WAS PERFORMING AN ABORTION PROCEDURE, AN IPAS EASYGRIP CANNULA BROKE. WE DID NOT RECEIVE INFO ABOUT WHERE IT BROKE -- AT THE TIP, AT THE BASE, SPLIT LENGTHWISE, ETC. WE DO NOT KNOW IF THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN PORTION FROM THE UTERUS. HE USED ANOTHER IPAS EASYGRIP CANNULA AND WE WERE INFORMED THAT IT ALSO BROKE. BOTH CANNULA WERE FROM THE SAME LOT NUMBER. THE UTERUS WAS PERFORATED AND A HYSTERECTOMY WAS PERFORMED. THROUGH THE DISTRIBUTOR, WE SUBMITTED A LIST OF QUESTIONS TO THE HOSP IN (B)(6), SEEKING A PT IDENTIFIER, THE LENGTH OF GESTATION, THE PHYSICIAN'S EXPERIENCE WITH PERFORMANCE OF MVA AND THE EASYGRIP CANNULAE. WE ASKED THEM TO (B)(4) US THE PIECES OF THE CANNULAE IF THE HOSP RETAINED THEM, OR IF NOT, TO INDICATE ON A PHOTO WE SENT TO THE DISTRIBUTOR WHERE THE CANNULAE BROKE. WE ALSO ASKED IF WE COULD OBTAIN A PATHOLOGY REPORT OF THE UTERUS. NO OTHER INFO IS AVAILABLE OTHER THAN THE INFO PROVIDED IN PAGES 1-2. IF AND WHEN ADD'L INFO BECOMES AVAILABLE, F/U INFO WILL BE PROVIDED TO THE FDA.
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WE ALSO ASKED IF WE COULD OBTAIN A PATHOLOGY REPORT OF THE UTERUS. WE ASKED IF THE CANNULAE WERE USED A SINGLE TIME OR IF THEY WERE REPROCESSED. WE ALSO ASKED FOR A MORE COMPLETE NARRATIVE OF THE EVENT. FOR INSTANCE, WE ASKED IF, AFTER THE INITIAL CANNULA BROKE, WAS IT RETRIEVED BEFORE A SECOND CANNULA WAS INTRODUCED. WE PROVIDED A LIST OF QUESTIONS THAT WOULD ADD CLARITY TO THE UNDERSTANDING OF THE EVENT, AND ASKED FOR THE CANNULAE THEMSELVES IN A DOCUMENT WHICH THE DISTRIBUTOR GAVE TO THE HOSP. THE DISTRIBUTOR INFORMED US THAT THE HOSP'S REPLY WAS: "PLEASE BE INFORMED THAT THE AUTHORITIES OF THE HOSP DENIED TO PROVIDE ANY ADD'L INFO RELATED TO THE ADVERSE EVENT. THEY SAID THAT THE INFO IS CONFIDENTIAL AND NO FURTHER INFO WOULD BE PROVIDED TO ANYBODY." WOMANCARE GLOBAL CONSULTED WITH TWO OB/GYNS IN THE UNITED STATES WHO HAVE EACH PERFORMED MVA PROCEDURES VIRTUALLY DAILY FOR 20 YEARS USING THE IPAS EASYGRIP CANNULAE. NEITHER OF THEM HAD EVER EXPERIENCED OR HEARD OF A CANNULA ACTUALLY BREAKING. A 6MM CANNULAE CAN BEND -- THAT IS EXPECTED AND ACTUALLY DESIRED IF IT IS APPLIED WITH FORCE AGAINST THE UTERINE WALL. (B)(4), WOMANCARE GLOBAL DIRECTOR OF PHARMACOVIGILANCE, TOOK AN UNUSED IPAS EASYGRIP CANNULA OUT OF ITS STERILE PACKAGE AND TRIED TO BREAK OFF THE TIP. AFTER REPEATED BENDING AND TWISTING, IT DID BEND BUT IT DIDN'T BREAK. WE HAVE NOT BEEN INFORMED BY ANY OTHER ORGANIZATION, DISTRIBUTOR OR HEALTHCARE PROVIDER ANYWHERE IN THE WORLD THAT A CANNULA BROKE. WE DO NOT HAVE THE CANNULAE THEMSELVES OR ANY DETAIL ABOUT HOW THE CANNULAE "BROKE". WE ARE UNABLE TO DISCERN WHETHER THERE WAS A DEFECT IN THESE PARTICULAR CANNULAE, THE CANNULAE BECAME BRITTLE DUE TO INCORRECT REPROCESSING OR THIS EVENT WAS DUE TO OPERATOR ERROR. WE WERE INFORMED THAT A PHYSICIAN PERFORMED THIS ELECTIVE ABORTION USING AN MVA DEVICE, PRESUMABLY THE IPAS MVAPLUS, ALTHOUGH THIS IS NOT VERIFIED. WE DO NOT KNOW IF THIS WAS AN EXPERIENCED PHYSICIAN OR A PHYSICIAN IN TRAINING. IF THE PHYSICIAN WAS IN TRAINING, WE DON'T KNOW IF HE/SHE WAS BEING SUPERVISED. WE DO NOT KNOW THE AGE OR PARITY OF THE PT OR IF SHE HAD AN ANOMALOUS UTERUS. WE DON'T KNOW AT WHAT POINT IN THE PROCEDURE IT WAS REALIZED THAT THE UTERUS WAS PERFORATED. WE DON'T KNOW IF THERE WAS BOWEL INVOLVEMENT. WE DON'T KNOW THE DATE OF HOSPITAL DISCHARGE OR THE CONDITION OF THE PT UPON DISCHARGE. DESPITE THE GENERAL POLICY IN THE FEDERAL DISTRICT OF (B)(6) THAT CANNULAE ARE SINGLE-USE DEVICES, WE DON'T KNOW IF THAT IS THE ACTUAL PRACTICE OR IF THESE PARTICULAR CANNULAE WERE USED A SINGLE TIME OR HAD BEEN REPROCESSED.