MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER GENESYS HTA PROCERVA®; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Model Number M006580210

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2014

Event Type  malfunction  

Event Description

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) 2014.According to the complainant, when the hysteroscope was inserted into the sheath, an image was visualized through the scope and was displayed on the monitor of what looked like red and blue fibers.The foreign matter was noted to be lodged on the sheath cap and the device was never inserted into the patient.The procedure was completed using another of the same device and the condition of the patient at the conclusion of the procedure was reported as "fine.".

Manufacturer Narrative

According to the complainant, the device was disposed of and is not available for evaluation.At this time, we are unable to determine the relationship between the device and the cause for this event.If there is any further relevant information received, a supplemental medwatch report will be filed.

• Brand Name: GENESYS HTA PROCERVA®
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3643326
• MDR Text Key: 4280457
• Report Number: 3005099803-2014-01178
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: M006580210
• Device Catalogue Number: 58021
• Device Lot Number: 16249745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1