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

Model Number	M00534340
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
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 mdr 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) 2021.During the procedure and inside the patient, when the physician attempted to advance the stent, difficulty was noticed.The guide catheter was shortened and the distal tip of the stent kinked due to the force used to get the stent up the bile duct.The physician attempted to remove the stent but it deployed prematurely and was stuck inside the scope.The stent was then pushed out of the scope using biopsy forceps.A different device was opened and used to successfully complete the procedure.Subsequently, the physician used a snare to grab and retrieve the original advanix stent.When attempting to pull the stent through the channel, the stent broke in half.Both pieces of the broken stent were then removed from the patient.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 good.
Additional Manufacturer Narrative
Block h6: medical device problem code a0401 captures the reportable event of stent break.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.Block h11: correction to d4: model number changed from m00534320 to m00534340 lot number changed from 0026236566 to 0026236567.
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), 2021.During the procedure and inside the patient, when the physician attempted to advance the stent, difficulty was noticed.The guide catheter was shortened and the distal tip of the stent kinked due to the force used to get the stent up the bile duct.The physician attempted to remove the stent but it deployed prematurely and was stuck inside the scope.The stent was then pushed out of the scope using biopsy forceps.A different device was opened and used to successfully complete the procedure.Subsequently, the physician used a snare to grab and retrieve the original advanix stent.When attempting to pull the stent through the channel, the stent broke in half.Both pieces of the broken stent were then removed from the patient.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 good.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12048664
• Report Number: 3005099803-2021-02929
• Device Sequence Number: 4428784
• Product Code: FGE
• UDI-Device Identifier: 08714729787419
• UDI-Public: 08714729787419
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 10/23/2022
• Device Model Number: M00534340
• Device Catalogue Number: 3434
• Device Lot Number: 0026236567
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1