FDA Adverse Event Injury Summary report: N

HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

MDR report key: 2833726 · Received November 15, 2012

Report

Report Number: 3005099803-2012-05212
Event Type: Injury
Date Received: November 15, 2012
Date of Event: October 8, 2012
Report Date: October 22, 2012
Manufacturer: BOSTON SCIENTIFIC - MARLBOROUGH
Product Code: MNB
PMA / PMN Number: P000040
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE LOT NUMBER IS NOT KNOWN PER COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CAN NOT BE DETERMINED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, A FLUID LOSS ALARM OCCURRED WITH ONLY A FEW SECONDS REMAINING IN THE ABLATION PHASE. DURING COOL DOWN, FLUID WAS NOTED TO BE LEAKING FROM THE PATIENT'S CERVIX. NO OTHER ALARMS OCCURRED DURING THE PROCEDURE. THE PATIENT RETURNED TO THE PHYSICIAN'S OFFICE ON (B)(6) 2012 WHERE IT WAS DETERMINED THAT THE PATIENT RECEIVED A BURN MEASURING 1CM X 2CM X 3CM TO THE PERINEUM BETWEEN THE INTROITUS AND RECTUM. THE PATIENT WAS TREATED WITH SYLVADENE. THE PATIENT RETURNED FOR A FOLLOW UP APPOINTMENT ON (B)(6) 2012 WHERE THE PHYSICIAN NOTED "SIGNIFICANT IMPROVEMENTS TOWARDS END OF HEALING PROCESS." THE PATIENT DECLINED A FUTURE APPOINTMENT. AN ADDITIONAL ATTEMPT HAS BEEN MADE TO OBTAIN FOLLOW UP EVENT 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	UNK675

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR