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

Model Number	M00500070
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Fever (1858); Inflammation (1932); Liver Damage/Dysfunction (1954); Thrombosis/Thrombus (4440)
Date of Event	03/18/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Exact patient age was not provided but patient was noted to be in his 80s.Approximated 10 days after the procedure date.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.The complainant indicated that the device was discarded and will not be returned for evaluation; therefore, a device analysis of could not be completed.If any further relevant information is identified, 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 without issues in the bile duct during a bile duct radio frequency treatment performed on (b)(6) 2022.The habib endohpb rf catheter was being used to treat a localized biliary malignancy.About 10 days post procedure, the patient presented with cholangitis accompanied with a 40 degrees celsius fever.The patient was treated with endoscopic nasobiliary drainage (enbd) antibiotics and was noted to have recovered.Later (exact date unknown), the patient again presented with cholangitis and a portal vein thrombosis was discovered.Then a coronary aneurysm from another thrombosis was noted.The coronary aneurysm could not be approached and the thrombosis could not be removed.The patient experience liver failure due to thrombosis.On (b)(6) 2022, the patient died due to liver failure.In the physician's assessment, patient's death could be related to the habib treatment.

• 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: 14918970
• Report Number: 3005099803-2022-03613
• Device Sequence Number: 5864004
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/05/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00500070
• 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: 06/10/2022
• Initial Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other; Death
• Patient Sex: Male