FDA Adverse Event Injury Summary report: N

HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

MDR report key: 2022900 · Received March 18, 2011

Report

Report Number: 3005099803-2011-00721
Event Type: Injury
Date Received: March 18, 2011
Report Date: February 25, 2011
Manufacturer: BOSTON SCIENTIFIC - MARLBOROUGH
Product Code: MNB
PMA / PMN Number: P000040
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WV, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, EXPIRATION AND MANUFACTURING DATES CANNOT BE DETERMINED. THE DEVICE HAS NOT BEEN RETURNED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THIS EVENT. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. (THE PATIENT ID, AGE, DATE OF BIRTH, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PHYSICIAN REPORTED A PATIENT THAT RETURNED 6 MONTHS POST PROCEDURE WITH SPOTTING AND MILD PAIN. THE PHYSICIAN PERFORMED A HYSTEROSCOPY AND WITHIN THE CAVITY, OBSERVED A SMALL BLOOD CLOT. THE PHYSICIAN REPORTED THE PRESENCE OF SCARRING IN THE UTERINE CAVITY WHICH PREVENTED THE BLOOD CLOT FROM ESCAPING. UPON REMOVAL OF THE BLOOD CLOT, THE PATIENT'S PAIN SUBSIDED. THERE WERE NO FURTHER COMPLICATIONS REPORTED WITH THIS EVENT.

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	UNK560

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention