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

Model Number M006580210

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

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 used in a hydrothermablation (hta) procedure performed on an unknown date.According to the complainant, during the procedure as the sheath was inserted into the patient¿s cervix, a visible crack was noticed at the tip of the sheath.There were no patient complications reported as a result of this event.Boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.

Manufacturer Narrative

Visual analysis of the returned genesys hta procerva procedure set sheath assembly was performed.There was no damage noted, there were no leaks observed.Analysis of the returned device showed no evidence of the alleged issue or any other defect, therefore; the most probable root cause is undeterminable.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database revealed that no other complaints exist for the specified batch.

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 an unknown date.According to the complainant, during the procedure as the sheath was inserted into the patient¿s cervix, a visible crack was noticed at the tip of the sheath.There were no patient complications reported as a result of this event.Boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.

• 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: 6045980
• MDR Text Key: 58027453
• Report Number: 3005099803-2016-03150
• 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: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: M006580210
• Device Catalogue Number: 58021
• Device Lot Number: 19187910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2016
• 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