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

Model Number	M00534280
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter facility name (b)(6).(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 used during an endoscopic retrograde cholangiopancreatography procedure in the bile duct, performed on (b)(6) 2022.During the procedure and inside the patient, when the physician attempted to deploy the stent, it failed to deploy as it got stuck when crossing the stenosis.The physician cut the guide catheter with a pair of foreign body pliers and withdrew the device.Another advanix biliary stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the bile duct, performed on (b)(6) 2022.During the procedure and inside the patient, when the physician attempted to deploy the stent, it failed to deploy as it got stuck when crossing the stenosis.The physician cut the guide catheter with a pair of foreign body pliers and withdrew the device.Another advanix biliary stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter facility name (b)(6).Block h6: impact code f23 captures the reportable event of unexpected medical intervention.Block h10: the returned advanix rx biliary stent was analyzed, and a visual evaluation noted that the stent was broken in two parts.The pull wire was kinked.Suture thread did not return and push catheter suture hole was torn.Functional inspection found the pull wire could be retracted and extended without issues.Microscope inspection revealed that the stent was broken, kinked and deformed, it was observed stretched at different sections.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, it was observed that the customer may have experienced difficulties during the deployment of the stent; it is possible that the technique applied and/or some factors encountered during procedure may have affected the overall performance of the device.Once these difficulties were present, the customer may have applied an extra force by retracting the pull wire which ended kinking it and tearing the suture hole of the push catheter.Based on the reported allegation of device difficult to remove and the observed issues along the stent it is most likely that after the failed deployment, the stent experienced tough movements towards the removal of it, the stretch marks found indicated that the stent was tensioned enough for causing the break and even the kinks observed.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 14404095
• Report Number: 3005099803-2022-02559
• Device Sequence Number: 14092775
• Product Code: FGE
• UDI-Device Identifier: 08714729787372
• UDI-Public: 08714729787372
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• 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: 01/21/2023
• Device Model Number: M00534280
• Device Catalogue Number: 3428
• Device Lot Number: 0026669398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 05/15/2022
• Supplement Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2021
• 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 Age: 50 YR
• Patient Sex: Female
• Patient Weight: 55 KG