HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
Report
- Report Number
- 3005099803-2011-01301
- Event Type
- Injury
- Date Received
- April 27, 2011
- Date of Event
- April 6, 2011
- Report Date
- April 6, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- MNB
- PMA / PMN Number
- P000040
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE COMPLAINANT HAS INDICATED THAT THE PRODUCT HAS BEEN DISPOSED OF AND THE DEVICE WILL NOT BE RETURNED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THIS EVENT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
ADDITIONAL FOLLOW UP INFORMATION RECEIVED (B)(6) 2011. THE CLINICIAN REPORTED THE PATIENT HAD A FOLLOW UP APPOINTMENT WITH THE PHYSICIAN. THE PHYSICIAN NOTED A LIGHT-COLORED RESIDUAL SCAR WHERE THE BURN WAS LOCATED. NO BLISTERS TO THE SKIN ARE VISIBLE. THE PATIENT IS NO LONGER APPLYING SILVADENE CREAM AS HOME TREATMENT. NO ADDITIONAL FOLLOW UP APPOINTMENTS WITH THE PHYSICIAN ARE SCHEDULED AND THE PATIENT IS DOING WELL.
A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN NOTICED A BURN ON THE PATIENT'S LEFT BUTTOCKS FROM THE TUBING THAT MEASURED APPROXIMATELY 1 INCH. THE PHYSICIAN TREATED THE BURN WITH SILVADENE CREAM. ADDITIONAL FOLLOW UP EVENT INFORMATION FROM THE PHYSICIAN REPORTED THE PATIENT HAD A BICORNUATE AND ANTEVERTED UTERUS. DUE TO THE PATIENT'S ANATOMY AND WEIGHT, THE DEVICE HAD TO BE PRESSED AGAINST THE PATIENT TO ACCESS THE UTERUS. DUE TO THE DEVICE BEING PRESSED AGAINST THE PATIENT, THE TUBING BURNED THE PATIENT ON THE LEFT SIDE OF THE BUTTOCKS. THE PORTION OF THE TUBING WHICH CONTACTED THE PATIENT WAS THE AREA WHICH CONNECTS TO THE TWO PORTS AT THE DISTAL END OF THE SHEATH. THE PHYSICIAN OBSERVED THE BURN DURING THE ABLATION PHASE OF THE PROCEDURE. ONCE THE BURN WAS NOTICED, A SURGICAL TOWEL WAS PLACED BETWEEN THE TUBING AND THE OTHER SIDE OF THE PATIENT'S BUTTOCKS AND THIS PROTECTED THE OTHER SIDE OF THE BUTTOCKS. AT THE DAY OF SURGERY ON (B)(6) 2011, THE SIZE OF THE BURN WAS ONE CONTIGUOUS AREA WHICH WAS APPROXIMATELY 4 CM LONG AND 2 CM WIDE AND SECOND DEGREE IN SEVERITY. NO CERVICAL LEAK OCCURRED DURING THE PROCEDURE. DUE TO THE EXTENDED LENGTH OF THE PROCEDURE, THE PATIENT WAS HOSPITALIZED ON (B)(6) 2011 TO MONITOR THE ELECTROLYTES AND THE STATUS OF THE BURN. WHEN THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2011, THE ELECTROLYTES WERE NORMAL AND THE BURN WAS HEALING. AS OF A FOLLOW UP APPOINTMENT WITH THE PHYSICIAN, THE PATIENT IS FINE. THE BURN IS HEALING AND VISIBLE AS TWO BLISTERS ON THE LEFT BUTTOCKS. THE APPROXIMATE SIZE OF 1 1/2 CM EACH. THE TWO AFFECTED AREAS ARE SECOND DEGREE IN SEVERITY. THE PATIENT WAS PROVIDED SILVADENE CREAM TO CONTINUE TREATMENT AT HOME TWICE DAILY. SILVADENE CREAM WAS ALSO APPLIED TO THE BURN AT THE DAY OF SURGERY, (B)(6) 2011. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED WITH THIS EVENT. THE CONDITION OF THE PATIENT IS REPORTED TO BE "FINE." AN ADDITIONAL ATTEMPT HAS BEEN MADE TO OBTAIN PATIENT FOLLOW UP DETAILS WITH NO RESPONSE FROM THE CLINICIAN.
A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2011.ACCORDING TO THE COMPLAINANT, THE PHYSICIAN NOTICED A BURN ON THE PATIENT'S LEFT BUTTOCKS FROM THE TUBING THAT MEASURED APPROXIMATELY 1 INCH. THE PHYSICIAN TREATED THE BURN WITH SILVADENE CREAM.ADDITIONAL FOLLOW UP EVENT INFORMATION FROM THE PHYSICIAN REPORTED THE PATIENT HAD A BICORNUATE AND ANTEVERTED UTERUS. DUE TO THE PATIENT'S ANATOMY AND WEIGHT, THE DEVICE HAD TO BE PRESSED AGAINST THE PATIENT TO ACCESS THE UTERUS. DUE TO THE DEVICE BEING PRESSED AGAINST THE PATIENT, THE TUBING BURNED THE PATIENT ON THE LEFT SIDE OF THE BUTTOCKS. THE PORTION OF THE TUBING WHICH CONTACTED THE PATIENT WAS THE AREA WHICH CONNECTS TO THE TWO PORTS AT THE DISTAL END OF THE SHEATH. THE PHYSICIAN OBSERVED THE BURN DURING THE ABLATION PHASE OF THE PROCEDURE. ONCE THE BURN WAS NOTICED, A SURGICAL TOWEL WAS PLACED BETWEEN THE TUBING AND THE OTHER SIDE OF THE PATIENT'S BUTTOCKS AND THIS PROTECTED THE OTHER SIDE OF THE BUTTOCKS. AT THE DAY OF SURGERY ON (B)(6) 2011, THE SIZE OF THE BURN WAS ONE CONTIGUOUS AREA WHICH WAS APPROXIMATELY 4 CM LONG AND 2 CM WIDE AND SECOND DEGREE IN SEVERITY. NO CERVICAL LEAK OCCURRED DURING THE PROCEDURE. DUE TO THE EXTENDED LENGTH OF THE PROCEDURE, THE PATIENT WAS HOSPITALIZED ON (B)(6) 2011 TO MONITOR THE ELECTROLYTES AND THE STATUS OF THE BURN. WHEN THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2011, THE ELECTROLYTES WERE NORMAL AND THE BURN WAS HEALING.AS OF A FOLLOW UP APPOINTMENT WITH THE PHYSICIAN, THE PATIENT IS FINE. THE BURN IS HEALING AND VISIBLE AS TWO BLISTERS ON THE LEFT BUTTOCKS. THE APPROXIMATE SIZE OF 1 1/2 CM EACH. THE TWO AFFECTED AREAS ARE SECOND DEGREE IN SEVERITY. THE PATIENT WAS PROVIDED SILVADENE CREAM TO CONTINUE TREATMENT AT HOME TWICE DAILY. SILVADENE CREAM WAS ALSO APPLIED TO THE BURN AT THE DAY OF SURGERY, (B)(6) 2011.THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED WITH THIS EVENT. THE CONDITION OF THE PATIENT IS REPORTED TO BE "FINE." AN ADDITIONAL ATTEMPT HAS BEEN MADE TO OBTAIN PATIENT FOLLOW UP DETAILS WITH NO RESPONSE FROM THE CLINICIAN.
A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN NOTICED A BURN ON THE PATIENT'S LEFT BUTTOCKS FROM THE TUBING THAT MEASURED APPROXIMATELY 1 INCH. THE PHYSICIAN TREATED THE BURN WITH SILVADENE CREAM. ADDITIONAL FOLLOW UP EVENT INFORMATION FROM THE PHYSICIAN REPORTED THE PATIENT HAD A BICORNUATE AND ANTEVERTED UTERUS. DUE TO THE PATIENT'S ANATOMY AND WEIGHT, THE DEVICE HAD TO BE PRESSED AGAINST THE PATIENT TO ACCESS THE UTERUS. DUE TO THE DEVICE BEING PRESSED AGAINST THE PATIENT, THE TUBING BURNED THE PATIENT ON THE LEFT SIDE OF THE BUTTOCKS. THE PORTION OF THE TUBING WHICH CONTACTED THE PATIENT WAS THE AREA WHICH CONNECTS TO THE TWO PORTS AT THE DISTAL END OF THE SHEATH. THE PHYSICIAN OBSERVED THE BURN DURING THE ABLATION PHASE OF THE PROCEDURE. ONCE THE BURN WAS NOTICED, A SURGICAL TOWEL WAS PLACED BETWEEN THE TUBING AND THE OTHER SIDE OF THE PATIENT'S BUTTOCKS AND THIS PROTECTED THE OTHER SIDE OF THE BUTTOCKS. AT THE DAY OF SURGERY ON (B)(6) 2011, THE SIZE OF THE BURN WAS ONE CONTIGUOUS AREA WHICH WAS APPROXIMATELY 4 CM LONG AND 2 CM WIDE AND SECOND DEGREE IN SEVERITY. NO CERVICAL LEAK OCCURRED DURING THE PROCEDURE. DUE TO THE EXTENDED LENGTH OF THE PROCEDURE, THE PATIENT WAS HOSPITALIZED ON (B)(6) 2011 TO MONITOR THE ELECTROLYTES AND THE STATUS OF THE BURN. WHEN THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2011, THE ELECTROLYTES WERE NORMAL AND THE BURN WAS HEALING. AS OF A FOLLOW UP APPOINTMENT WITH THE PHYSICIAN, THE PATIENT IS FINE. THE BURN IS HEALING AND VISIBLE AS TWO BLISTERS ON THE LEFT BUTTOCKS. THE APPROXIMATE SIZE OF 1 1/2 CM EACH. THE TWO AFFECTED AREAS ARE SECOND DEGREE IN SEVERITY. THE PATIENT WAS PROVIDED SILVADENE CREAM TO CONTINUE TREATMENT AT HOME TWICE DAILY. SILVADENE CREAM WAS ALSO APPLIED TO THE BURN AT THE DAY OF SURGERY, (B)(6) 2011. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED WITH THIS EVENT. THE CONDITION OF THE PATIENT IS REPORTED TO BE "FINE." AN ADDITIONAL ATTEMPT HAS BEEN MADE TO OBTAIN PATIENT FOLLOW UP DETAILS WITH NO RESPONSE FROM THE CLINICIAN.
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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Hospitalization| R |