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 08/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis.Upon 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

(b)(4).

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.(b)(4).

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: 5046281
• MDR Text Key: 24767147
• Report Number: 3005099803-2015-02391
• 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: Health Professional
• Type of Report: Followup
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/30/2017
• Device Model Number: M006580210
• Device Catalogue Number: 58021
• Device Lot Number: 17894652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2015
• 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