BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 2103617 · Received May 26, 2011

    Report

    Report Number
    3005099803-2011-01716
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012 CHANGED PATIENT AGE. AGE AT TIME OF EVENT: WAS: (B)(6), CHANGED TO: (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE SHEATH ASSEMBLY CAME APART AT THE AREA OF THE BLACK O-RING. THE PROBLEM WAS NOTICED APPROXIMATELY 1 MINUTE INTO THE ABLATION PHASE, WHEN THE PHYSICIAN FELT FLUID ON HER HAND. IMMEDIATELY AFTER NOTICING THE FLUID, THE CONSOLE INDICATED A 120 CC/MIN FLUID LOSS. AT THIS POINT, THE PHYSICIAN BELIEVED THE LEAK WAS OF NO HARM TO THE PATIENT. THE PHYSICIAN PUSHED THE SHEATH ASSEMBLY BACK TOGETHER AND PROCEEDED TO THE COOL DOWN PHASE. THE PROCEDURE WAS COMPLETED WITH A SECOND PROCEDURE SET WITH NO ABNORMALITIES NOTED. HOWEVER, AT THE CONCLUSION OF THE PROCEDURE, THE PHYSICIAN NOTICED A BURN ON THE INSIDE OF THE PATIENT'S RIGHT THIGH. UPON FURTHER EXAMINATION, THE PATIENT'S VAGINA APPEARED TO BE RED, HOWEVER THE PHYSICIAN WAS UNSURE IF A VAGINAL BURN OCCURRED. THE PHYSICIAN APPLIED SILVADENE CREAM TO THE THIGH AND VAGINA. THE PATIENT WAS EXAMINED BY A DIFFERENT PHYSICIAN A FEW DAYS POST PROCEDURE. THE PHYSICIAN REPORTED THAT THE PATIENT WAS IN TOO MUCH PAIN FOR A VAGINAL EXAM. AN ADDITIONAL ATTEMPT HAS BEEN MADE TO OBTAIN FOLLOW UP EVENT DETAILS WITH NO RESPONSE FROM THE CLINICIAN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 CONFIRMED THE PATIENT WAS EVALUATED BY DR(B)(6), WHO DOCUMENTED THAT THE PATIENT HAD A SECOND-DEGREE THERMAL INJURY TRACKING FROM JUST INSIDE THE POSTERIOR FOURCHETTE DOWN THE PERINEAL BODY ACROSS THE LEFT INNER THIGH AND EXTENDING DOWN THE RIGHT THIGH. THERE WAS NO EVIDENCE OF NECROSIS OR INFECTION. PATIENT WAS GIVEN HYDROCODONE FOR THE PAIN, AND STARTED ON KEFLEX FOR ANTIBIOTIC PROPHYLAXIS. A 50/50 MIXTURE OF SILVADENE CREAM AND 2% LIDOCAINE JELLY WAS PLACED ON THE THERMAL INJURY. PATIENT WAS INSTRUCTED TO APPLY THREE TIMES DAILY FOR THE NEXT SEVERAL DAYS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2011 THAT A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE SHEATH ASSEMBLY CAME APART AT THE AREA OF THE BLACK O-RING. THE PROBLEM WAS NOTICED APPROXIMATELY 1 MINUTE INTO THE ABLATION PHASE, WHEN THE PHYSICIAN FELT FLUID ON HER HAND. IMMEDIATELY AFTER NOTICING THE FLUID, THE CONSOLE INDICATED A 120 CC/MIN FLUID LOSS. AT THIS POINT, THE PHYSICIAN BELIEVED THE LEAK WAS OF NO HARM TO THE PATIENT. THE PHYSICIAN PUSHED THE SHEATH ASSEMBLY BACK TOGETHER AND PROCEEDED TO THE COOL DOWN PHASE. THE PROCEDURE WAS COMPLETED WITH A SECOND PROCEDURE SET WITH NO ABNORMALITIES NOTED. HOWEVER, AT THE CONCLUSION OF THE PROCEDURE, THE PHYSICIAN NOTICED A BURN ON THE INSIDE OF THE PATIENT'S RIGHT THIGH. UPON FURTHER EXAMINATION, THE PATIENT'S VAGINA APPEARED TO BE RED, HOWEVER THE PHYSICIAN WAS UNSURE IF A VAGINAL BURN OCCURRED. THE PHYSICIAN APPLIED SILVADENE CREAM TO THE THIGH AND VAGINA. THE PATIENT WAS EXAMINED BY A DIFFERENT PHYSICIAN A FEW DAYS POST PROCEDURE. THE PHYSICIAN REPORTED THAT THE PATIENT WAS IN TOO MUCH PAIN FOR A VAGINAL EXAM. AN ADDITIONAL ATTEMPT HAS BEEN MADE TO OBTAIN FOLLOW UP EVENT DETAILS WITH NO RESPONSE FROM THE CLINICIAN. ADDITIONAL INFORMATION RECEIVED (B)(4) 2012 STATES: "ON (B)(6) 2011, THE PATIENT SAW HER PRIMARY CARE PHYSICIAN COMPLAINING OF THE BURN SHE RECEIVED AS A RESULT OF THE HYDRO THERM ABLATION. HER PRIMARY CARE PHYSICIAN DID NOT PROVIDE ANY SPECIFIC TREATMENT NOR DID SHE REFER HER TO A SPECIALIST TO ADDRESS THE COMPLAINTS REGARDING THE BURN. THE PATIENT RETURNED TO HER PRIMARY CARE PHYSICIAN ON (B)(6) 2011 AND THERE WAS NO MENTION OF HER BURN. THERE ARE NO MEDICAL RECORDS FOR ANY TREATMENT AFTER (B)(6) 2011 REGARDING HER BURN. IT APPEARS THAT THE PATIENT SUFFERED A VERY MINOR BURN, IF ANY AT ALL."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2011 THAT A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE SHEATH ASSEMBLY CAME APART AT THE AREA OF THE BLACK O-RING. THE PROBLEM WAS NOTICED APPROXIMATELY 1 MINUTE INTO THE ABLATION PHASE, WHEN THE PHYSICIAN FELT FLUID ON HER HAND. IMMEDIATELY AFTER NOTICING THE FLUID, THE CONSOLE INDICATED A 120 CC/MIN FLUID LOSS. AT THIS POINT, THE PHYSICIAN BELIEVED THE LEAK WAS OF NO HARM TO THE PATIENT. THE PHYSICIAN PUSHED THE SHEATH ASSEMBLY BACK TOGETHER AND PROCEEDED TO THE COOL DOWN PHASE. THE PROCEDURE WAS COMPLETED WITH A SECOND PROCEDURE SET WITH NO ABNORMALITIES NOTED. HOWEVER, AT THE CONCLUSION OF THE PROCEDURE, THE PHYSICIAN NOTICED A BURN ON THE INSIDE OF THE PATIENT'S RIGHT THIGH. UPON FURTHER EXAMINATION, THE PATIENT'S VAGINA APPEARED TO BE RED, HOWEVER, THE PHYSICIAN WAS UNSURE IF A VAGINAL BURN OCCURRED. THE PHYSICIAN APPLIED SILVADENE CREAM TO THE THIGH AND VAGINA. THE PATIENT WAS EXAMINED BY A DIFFERENT PHYSICIAN A FEW DAYS POST PROCEDURE. THE PHYSICIAN REPORTED THAT THE PATIENT WAS IN TOO MUCH PAIN FOR A VAGINAL EXAM. AN ADDITIONAL ATTEMPT HAS BEEN MADE TO OBTAIN FOLLOW UP EVENT DETAILS WITH NO RESPONSE FROM THE CLINICIAN. ADDITIONAL INFORMATION RECEIVED (B)(4) 2012 STATES: "ON (B)(6) 2011, THE PATIENT SAW HER PRIMARY CARE PHYSICIAN COMPLAINING OF THE BURN SHE RECEIVED AS A RESULT OF THE HYDRO THERM ABLATION. HER PRIMARY CARE PHYSICIAN DID NOT PROVIDE ANY SPECIFIC TREATMENT NOR DID SHE REFER HER TO A SPECIALIST TO ADDRESS THE COMPLAINTS REGARDING THE BURN. THE PATIENT RETURNED TO HER PRIMARY CARE PHYSICIAN ON (B)(6) 2011 AND THERE WAS NO MENTION OF HER BURN. THERE ARE NO MEDICAL RECORDS FOR ANY TREATMENT AFTER (B)(6) 2011 REGARDING HER BURN. IT APPEARS THAT THE PATIENT SUFFERED A VERY MINOR BURN, IF ANY AT ALL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - MARLBOROUGH M006560211 0000041257

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention