MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HABIB ENDOHPB; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00500070

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.

Event Description

It was reported to boston scientific corporation on (b)(6) 2023 that a habib endohpb rf catheter was used to treat an inoperable ampullary malignant tumor during a radiofrequency ablation procedure performed on (b)(6) 2023.The lesion was not dilated prior to the first attempt at ablation.During the procedure, the device was unable to deliver energy and the lesion could not be ablated.Furthermore, there was no blanching of the tissue noted.The procedure was not completed due to the availability of the device.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation on (b)(6) 2023 that a habib endohpb rf catheter was used to treat an inoperable ampullary malignant tumor during a radiofrequency ablation procedure performed on (b)(6) 2023.The lesion was not dilated prior to the first attempt at ablation.During the procedure, the device was unable to deliver energy and the lesion could not be ablated.Furthermore, there was no blanching of the tissue noted.The procedure was not completed due to the availability of the device.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

Manufacturer Narrative

Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: a habib endohpb rf catheter was received for analysis.Analysis of the returned device found the tube strongly damaged.Both electrodes were noted to have worked (glue has turned to yellow color); however, there is no connection noted at the proximal electrode.No other problems with the device were noted.Product analysis confirmed the reported event of device failure to deliver energy.It is most likely that the reported event was due to the observed event of catheter bent/kinked and that the device was damaged during use.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.

• Brand Name: HABIB ENDOHPB
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): STATICE MANUFACTURING; 9 rue thomas edison; besancon 25000 ; FR 25000
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17449970
• MDR Text Key: 320295287
• Report Number: 3005099803-2023-04079
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729981909
• UDI-Public: 08714729981909
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K231533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00500070
• Device Catalogue Number: 0007
• Device Lot Number: 0578810010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2022
• 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
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 65 KG