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

Model Number M00500070

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pancreatitis (4481); Restenosis (4576); Insufficient Information (4580)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to be (b)(6) 2021 as no specific event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on march 22, 2021 that a habib endohpb rf catheter was used to treat an ampullary adenoma during a radiofrequency ablation (rfa) procedure performed some time in 2020.On an unknown date, the patient developed a stricture in the proximal common bile duct.The physician suspects that the stricture was related to the previous use of the habib during the radiofrequency ablation (rfa) procedure or related to the disease progression of the ampullary adenoma.A plastic stent was implanted to treat the stricture.The patient's condition at the conclusion of the procedure is unknown.

Event Description

It was reported to boston scientific corporation on march 22, 2021 that a habib endohpb rf catheter was used to treat an ampullary adenoma during a radiofrequency ablation (rfa) procedure performed some time in 2020.On an unknown date, the patient developed a stricture in the proximal common bile duct.The physician suspects that the stricture was related to the previous use of the habib during the radiofrequency ablation (rfa) procedure or related to the disease progression of the ampullary adenoma.A plastic stent was implanted to treat the stricture.The patient's condition at the conclusion of the procedure is unknown.Additional information received on april 21, 2021 and april 22, 2021.On (b)(6) 2021, during a scheduled follow-up procedure, the patient presented with pancreatitis and cholangitis caused by the developed stricture.Consequently, an endoscopic retrograde cholangiopancreatography (ercp) procedure was performed to implant a plastic stent to treat the stricture.In the physician's assessment, the pancreatitis and cholangitis were a result of the stricture.It is unknown if the stricture was caused by the habib catheter or secondary to the initial endoscopy ampullary adenoma removal procedure.

Manufacturer Narrative

Blocks b3, b5, and h6 (patient codes) have been updated with additional information received on april 21, 2021 and april 22, 2021.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: patient code e233701 captures the reportable patient issue of stricture formation.Patient code e1021 captures the reportable patient issue of pancreatitis.Patient code e2326 captures the reportable patient issue of cholangitis.Impact code f2301 captures the additional intervention of plastic stent placement procedure.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: HABIB ENDOHPB
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11673614
• MDR Text Key: 246431293
• Report Number: 3005099803-2021-01759
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729981909
• UDI-Public: 08714729981909
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

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
• Device Operator: Health Professional
• Device Model Number: M00500070
• Device Catalogue Number: 2244-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 04/21/2021
• Supplement Dates FDA Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention