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 Code	Burn(s) (1757)
Date of Event	11/01/2010
Type of Reportable Event	Serious Injury
Event or Problem Description
Boston scientific became aware of events involving a habib rf catheter through the article "endoscopic radiofrequency ablation for malignant biliary obstruction: a nationwide retrospective study of 84 consecutive applications" by dr.Werner dolak, et al.A total of 58 patients underwent 84 radiofrequency ablation procedures to treat a malignant biliary obstruction performed in between november 2010 and december 2012.All 84 rfa procedures were conducted without any technical problems; 78 were performed via ercp and 6 were performed via a percutaneous approach.A total of 15 rfa procedures were performed within a previously implanted self-expanding metal stent.According to the literature, on one rfa procedure, a 10w was applied for 90 seconds at six different stricture locations in the common bile duct and both main biliary branches.However, a partial liver infarction was noted after the rfa procedure.It is unknown how the partial liver infarction was addressed and the patient was discharged after 8 days.Furthermore, a computer tomography scan (ct) was performed 3 months post rfa procedure and it showed normal perfusion of the affected liver areas.
Additional Manufacturer Narrative
Approximated based on the month and year the first procedures were performed.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Literature source: dolak, w., schreiber, f., schwaighofer, h., gschwantler, m., plieschnegger w., ziachehabi, a., mayer, a., kramer, l., kopecky, a., schrutka-kolbl, c., wolkersdorfer, g., madl, c., berr, f., trauner, m., puspok, a.Endoscopic radiofrequency ablation for malignant biliary obstruction: a nationwide retrospective study of 84 consecutive applications.Springer science+business media new york 2013; 28: 854-860.(b)(4).

• 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): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16269103
• Report Number: 3005099803-2023-00324
• Device Sequence Number: 6522550
• Product Code: KNS
• UDI-Device Identifier: 08714729981909
• UDI-Public: 08714729981909
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00500070
• Device Catalogue Number: 0007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/30/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown