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

Model Number M006580211

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a genesys hydrothermablation procerva procedure set was opened for use in a hydrothermablation (hta) procedure performed on (b)(6) 2015.According to the complainant, when they opened the packaging, a hair was found inside the sheath assembly.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient condition was reported to be "fine.".

Manufacturer Narrative

Visual analysis of the returned genesys hta procerva procedure set sheath assembly revealed the presence of a hair.The defect was identified outside the patient during preparation for the procedure.It cannot be determined if the hair came from the device assembly process or from the user after the package was opened; therefore the most probable root cause is undeterminable.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.

Event Description

It was reported to boston scientific corporation that a genesys hydrothermablation procerva procedure set was opened for use in a hydrothermablation (hta) procedure performed on (b)(6) 2015.According to the complainant, when they opened the packaging, a hair was found inside the sheath assembly.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient condition was reported to be "fine.".

• 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: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5331518
• MDR Text Key: 34525248
• Report Number: 3005099803-2015-03767
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M006580211
• Device Catalogue Number: 58021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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