MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANIX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00534300
Medical Device Problem Codes	Use of Device Problem (1670); Positioning Problem (3009)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Perforation (2001); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/27/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
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 remains implanted 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 or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was placed via percutaneous cholecystostomy during a procedure in the gall bladder and cystic duct, performed on (b)(6) 2022.During the procedure, when the physician attempted to deploy the stent, the proximal flange got stuck stuck (may have caught on the introducer sheath) which prevented the stent from deploying in the correct position.The physician believed that this may have caused a perforation of the gall bladder resulting in the proximal end of the stent deployed in the peritoneum.The patient was then referred for a follow up endoscopic retrograde cholangiopancreatography procedure to pull the other side of the stent from the duodenum and correct the stent placement.On the same day, the follow ercp was successfully completed.Post procedure, the patient woke up and then went to cardiac arrest which resulted to death.The physician believed it was due to anesthetic reaction.
Additional Manufacturer Narrative
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: impact code f02 captures the reportable event of death.Impact code f2202 captures the reportable event of endoscopic procedure.Block h11: correction to block h1: type of reportable event.Correction to block h6: patient code; device code.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was placed via percutaneous cholecystostomy during a procedure in the gall bladder and cystic duct, performed on (b)(6) 2022.During the procedure, when the physician attempted to deploy the stent, the proximal flange got stuck stuck (may have caught on the introducer sheath) which prevented the stent from deploying in the correct position.The physician believed that this may have caused a perforation of the gall bladder resulting in the proximal end of the stent deployed in the peritoneum.The patient was then referred for a follow up endoscopic retrograde cholangiopancreatography procedure to pull the other side of the stent from the duodenum and correct the stent placement.On the same day, the follow ercp was successfully completed.Post procedure, the patient woke up and then went to cardiac arrest which resulted to death.The physician believed it was due to anesthetic reaction.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was placed via percutaneous cholecystostomy during a procedure in the gall bladder and cystic duct, performed on (b)(6) 2022.During the procedure, when the physician attempted to deploy the stent, the proximal flange got stuck which prevented the stent from deploying in the correct position.The physician believed that this may have caused a perforation of the gall bladder resulting in the proximal end of the stent deployed in the peritoneum.The patient was then referred for a follow up endoscopic retrograde cholangiopancreatography procedure to pull the other side of the stent from the duodenum and correct the stent placement.On the same day, the follow ercp was successfully completed.Post procedure, the patient woke up and then went to cardiac arrest which resulted to death.The physician believed it was due to anesthetic reaction.
Additional Manufacturer Narrative
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: impact code f02 captures the reportable event of death.Impact code f2202 captures the reportable event of endoscopic procedure.Impact code e2114 captures the reportable event of perforation.Patient code e2402 captures the reportable event of anesthesia reaction.Block h11: correction to block h6 patient codes.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15065303
• Report Number: 3005099803-2022-03708
• Device Sequence Number: 5722815
• Product Code: FGE
• UDI-Device Identifier: 08714729787396
• UDI-Public: 08714729787396
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00534300
• Device Catalogue Number: 3430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 08/19/2022; 09/21/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 09/16/2022; 10/19/2022
• 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: Required Intervention; Death
• Patient Sex: Unknown