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 Code	Perforation (2001)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Boston scientific became aware of an event involving a habib endohpb radiofrequency catheter through the article gastrointestinal: pancreatic duct perforation following endoscopic intraductal radiofrequency ablation for pancreatic duct stricture.According to the literature, a habib radiofrequency catheter was used during an intraductal radiofrequency ablation procedure to treat a pancreatic structure.It was reported that the patient's pancreatic stricture had been previously treated twice by temporary stent placement; however, the symptomatic stricture recurred.Therefore, endoscopic radiofrequency ablation (rfa) for the stricture was planned to obtain long-term resolution.Following pancreatic duct cannulation and guidewire placement, a habib endohpb catheter was inserted over the guidewire.Rfa was performed on the pancreatic head duct stricture for 90 seconds at a power of 7 watts.Following rfa, an 8.5-fr plastic stent was placed across the stricture.There were no adverse events.Four months later, a pancreatic duct perforation was observed based on the overflow of the contrast medium to the outside of the pancreatic duct post-stent removal.Therefore, a plastic stent was placed across the perforation.During the 4-month follow-up period, the patient was asymptomatic, and no abnormal findings were detected on computed tomography (only plain ct was undertaken due to chronic kidney disease).
Additional Manufacturer Narrative
Block b3: approximated based on the year the article was published.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: t.Inoue, r.Kitano and m.Yoneda.Gastrointestinal: pancreatic duct perforation following endoscopic intraductal radiofrequency ablation for pancreatic duct stricture.Journal of gastroenterology and hepatology.2022 may;37(5):780.Doi: 10.1111/jgh.15724.Patient code e2114 captures the perforation.Impact code f2301 captures the additional plastic stent required.Impact code f2202 captures the additional procedure.

• 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: 17449778
• Report Number: 3005099803-2023-04157
• Device Sequence Number: 7415974
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2023

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: 07/10/2023
• Initial Report FDA Received Date: 08/03/2023
• 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: 71 YR
• Patient Sex: Male