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

Model Number	M00534200
Medical Device Problem Codes	Difficult to Remove (1528); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was initially implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct, performed on (b)(6) 2021.During a planned stent removal, the physician found that the advanix biliary stent had migrated proximally in the common bile duct.It was reported that they were not able to remove the migrated advanix biliary stent successfully and the patient was transferred to a different hospital.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Medical device code: (b)(4).Medical device code: (b)(4).Impact code: (b)(6).The complainant indicated that the device is not available for return; therefore, a problem 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 initially implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct, performed on (b)(6), 2021.During a planned stent removal, the physician found that the advanix biliary stent had migrated proximally in the common bile duct.It was reported that they were not able to remove the migrated advanix biliary stent successfully and the patient was transferred to a different hospital.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device code a010402 captures the reportable event of stent migration.Medical device code a150207 captures the reportable event of stent difficult to remove.Impact code f05 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the complainant indicated that the device is not available for return; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Correction to block e1: initial reporter email: www.Ssmhealth.Com.

• 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: 13978770
• Report Number: 3005099803-2022-01487
• Device Sequence Number: 5413473
• Product Code: FGE
• UDI-Device Identifier: 08714729787297
• UDI-Public: 08714729787297
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/22/2023
• Device Model Number: M00534200
• Device Catalogue Number: 3420
• Device Lot Number: 0026851388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2021
• 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
• Patient Age: 39 YR
• Patient Sex: Female