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

Model Number	M00500070
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a habib endohpb rf catheter was used in the biliary tree-hepatic duct to ablate a malignant biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.The patient's anatomy was tight and difficult to traverse.During the procedure, the endohpb rf catheter was able to ablate three different areas; however, upon removal of the rfa catheter, the two stainless steel electrodes detached and remained in the patient's duct.The two stainless steel electrodes was swept using a balloon catheter and the procedure was completed.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation on june 22, 2022 that a habib endohpb rf catheter was used in the biliary tree-hepatic duct to ablate a malignant biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.The patient's anatomy was tight and difficult to traverse.During the procedure, the endohpb rf catheter was able to ablate three different areas; however, upon removal of the rfa catheter, the two stainless steel electrodes detached and remained in the patient's duct.The two stainless steel electrodes was swept using a balloon catheter and the procedure was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: medical device problem code a0501 captures the reportable event of electrode detached.Block h10: a habib endohpb catheter was received for analysis.The inspection showed crimping marks (as the traces are deep into the tube).Glue traces are visible on the tube.The stainless steel electrodes have not been send back reducing the analysis possibilities.No further analysis possible without the electrode.Product analysis confirmed the reported event of electrode detachment.Based on the available information, during ablation the electrodes heat the tube, the tube becomes softer which may cause crimping.Also, there were 3 ablations at different areas, which may have further softened the tube.Also, the patient was being treated for a malignant biliary stricture and the patient's anatomy was tight and difficult to traverse.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to patient condition.A product labeling review identified that the device was used per the directions for use (dfu) / product label.

• Brand Name: HABIB ENDOHPB
• Common Device Name: 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: 15017709
• Report Number: 3005099803-2022-03824
• Device Sequence Number: 2316665
• Product Code: KNS
• UDI-Device Identifier: 08714729981909
• UDI-Public: 08714729981909
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K180165
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00500070
• Device Catalogue Number: 2244-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown