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

Model Number	2244-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Non specific EKG/ECG Changes (1817); Hyperkalemia (4824)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the year the article was published.Block e1: initial reporter facility name: (b)(6).Block d4, h4: the suspect device lot number was not provided in the article; therefore, the lot expiration and device manufacture dates are unknown.Block g2 literature source: inoue t, et al."hyperkalemia after endobiliary radiofrequency ablation for malignant biliary obstruction".Dig endosc.2021 jul;33(5):874-875.Doi: 10.1111/den.13989.Block h6: patient code (b)(6) captures the bradycardia.Patient code (b)(6) captures the hyperkalemia.Patient code (b)(6) captures the flattening p-waves and prolonged qrs complex.Impact code f2303 captures the calcium and glucose insulin was administered.
Event or Problem Description
Boston scientific became aware of an event involving a habib endohpb radio frequency ablation catheter through the article "hyperkalemia after endobiliary radiofrequency ablation for malignant biliary obstruction", by inoue t, et al.According to the literature, endoscopic transpapillary drainage failed because of tumor invasion to the duodenum, and endoscopic ultrasound-guided drainage was attempted.After penetrating the left intrahepatic duct via the stomach, a guidewire was passed through the lower bile duct stricture.The fistula was dilated using a 4-mm dilatation balloon catheter, and a habib endohpb radio frequency ablation catheter was inserted.Subsequently, the stricture was ablated at a power of 7 watts for 90 seconds.A metallic stent was deployed antegrade across the stricture, and a single-pigtail plastic stent was deployed across the fistula.The patients vital signs were stable during the procedure.However, severe bradycardia occurred 2 hours later with their heart rate plummeting below 20 to 30 beats per minute (bpm) and electrocardiogram showing flattened p-waves and prolonged qrs complex.A blood test revealed serum potassium levels of 7.4 meq/l, which had been 4.6 meq/l at pre-procedure.Calcium was administered immediately, and glucose-insulin therapy was initiated.One hour later, serum potassium levels decreased to 5.8 meq/l and stabilized at 4.8 meq/l 12 h later.The patients symptoms gradually improved.No further information has been obtained despite good faith efforts.

• 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; beacon 25000 ; FR 25000
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17571246
• Report Number: 3005099803-2023-04371
• Device Sequence Number: 15675043
• Product Code: KNS
• UDI-Device Identifier: 08714729981909
• UDI-Public: 08714729981909
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Literature,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 2244-01
• Device Catalogue Number: 2244-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male