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

Model Number M006580211

Device Problems Break (1069); Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

This manufacturer report pertains to one of two genesys procedure set used in the same procedure.It was reported to boston scientific corporation on (b)(6) 2019 that two genesys procedure set was used in a hta procedure in the uterus performed on (b)(6) 2019.According to the complainant, during the procedure and 7 minutes into the ablation phase, the procedure sheath broke at the connection part near the scope adaptor.A second genesys procedure set was used and the same issue occurred.Reportedly, there were no burn marks noted by the physician to the patient as a result of the leaking fluid during the case.The procedure was not completed due to this event.There were no serious injury nor adverse patient effects reported as a result of this event.

Event Description

This manufacturer report pertains to one of two genesys procedure set used in the same procedure.It was reported to boston scientific corporation on april 29, 2019 that two genesys procedure set was used in a hta procedure in the uterus performed on (b)(6) 2019.According to the complainant, during the procedure and 7 minutes into the ablation phase, the procedure sheath broke at the connection part near the scope adaptor.A second genesys procedure set was used and the same issue occurred.Reportedly, there were no burn marks noted by the physician to the patient as a result of the leaking fluid during the case.The procedure was not completed due to this event.There were no serious injury nor adverse patient effects reported as a result of this event.

Manufacturer Narrative

(b)(4).Investigation results: a genesys hta cassette was returned for investigation.The analysis of the returned product revealed that the genesys hta cassette had the communication board contacts corroded and broken.The level sensor board (lsb) was intact.The genesys hta sheath had the molded end piece detached from the sub assembly body.It is important to mention that residues of glue were observed in the area of the molded end piece, where it should be placed, indicating that the component was properly bonded.It was possible that force applied while attaching the sheath to the scope adapter or tightening the scope adapter to the sheath could have damaged the device components, contributing with the reported issues, additionally once the molded end piece detaches from the sub assembly body it would cause a leak of fluid, therefore the reported issues of "procedure set fluid leak from sheath and sheath damaged" were confirmed.The genesys hta system user's manual ((b)(4) rev aa) system setup section stated that the cassette should be inspected after opening and not to use if damage was seen.Thus, the contacts on the communications board were most likely not corroded or broken when the procedure set was first used.The corrosion most probably occurred post procedure as a result of saline exposure; this could have affected the integrity of the contacts causing degradation (weakness) to the contacts; once the contacts are affected by the corrosion they can broke easily.It can therefore be concluded that corroded/broken contacts most likely did not contribute to the complaint event.All compiled information on this investigation determined that the most probable cause is: adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.A dhr (device history record) review was performed and no deviations were found.

• Brand Name: GENESYS HTA PROCERVA
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 8632373
• MDR Text Key: 145786254
• Report Number: 3005099803-2019-02646
• Device Sequence Number: 1
• Product Code: MNB
• UDI-Device Identifier: 08714729809463
• UDI-Public: 08714729809463
• Combination Product (y/n): N
• PMA/PMN Number: P000040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2021
• Device Model Number: M006580211
• Device Catalogue Number: 58021
• Device Lot Number: 23512827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Date Manufacturer Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1