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

Model Number	3428
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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) 2022.On (b)(6) 2022, a planned stent removal procedure was performed.When the physician attempted to remove the stent with a pair of rat tooth, the stent was difficult to remove and a part of the stent tore off and was left in the common bile duct.The procedure was completed leaving the broken piece of stent in the patient and it was reported that the patient was referred to another facility to perform an additional procedure of sphincterotomy by doing a balloon sweep to remove the broken biliary stent.There were no patient complications reported as a result of this event.
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) 2022.On (b)(6) 2022, a planned stent removal procedure was performed.When the physician attempted to remove the stent with a pair of rat tooth, the stent was difficult to remove and a part of the stent tore off and was left in the common bile duct.The procedure was completed leaving the broken piece of stent in the patient and it was reported that the patient was referred to another facility to perform an additional procedure of sphincterotomy by doing a balloon sweep to remove the broken biliary stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a0401 captures the reportable event of stent break.Medical device problem code a150207 captures the reportable event of stent difficult to remove.Patient code e2008 captures the reportable event of un-retrieved device fragment.Impact code f05 delay to treatment/therapy captures the reportable event of delay to treatment/therapy.Impact code f23 captures the reportable event of unexpected medical intervention.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

• 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: 14553107
• Report Number: 3005099803-2022-02824
• Device Sequence Number: 12147874
• Product Code: FGE
• UDI-Device Identifier: 08714729787372
• UDI-Public: 08714729787372
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

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 Expiration Date: 04/01/2023
• Device Model Number: 3428
• Device Catalogue Number: M00534280
• Device Lot Number: 0027072803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female