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

Model Number M00534330

Device Problem Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2022

Event Type  malfunction  

Event Description

Note: this report is one of three complaints that pertain to the same event (mfr report #3005099803-2022-06245, mfr report #3005099803-2022-06268 and mfr.Report #3005099803-2022-06270).It was reported to boston scientific corporation that three advanix biliary stents were used during an endoscopic retrograde cholangiopancreatography procedure in the bile duct, performed on (b)(6) 2022.During the procedure, the physician had difficulty pushing the stents out of the endoscope.The patient had a bile duct anomaly and the physician did not have a good vision of the stent going into the bile duct.A blue area was visualized on the screen but the physician could not determine if the first stent was deployed.It appeared as though a part of the stent may have been blocking the lens view.The first stent was deployed prematurely and was then removed from the patient.There was difficulty in deploying the second stent as it appeared lost in the view but was then successfully deployed in the anatomy.The physician removed the endoscope and the third stent was successfully deployed.As a result, there was an approximately one and a half hour surgical delay and the intended procedure was not completed.The patient was scheduled to return the next day to have the implanted stents removed by interventional radiology and new stents were successfully implanted.The customer reported it was unclear if there was an internal channel issue of the endoscope or if the distal cover contributed to any stent deployment issues.The distal cover and endoscope were inspected prior to the procedure and there were no issues identified.The distal cover was not inspected after the procedure for issues.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

(b)(4).

• Brand Name: ADVANIX BILIARY
• Type of Device: 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: 15730065
• MDR Text Key: 307564959
• Report Number: 3005099803-2022-06245
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729787426
• UDI-Public: 08714729787426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/03/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2023
• Device Model Number: M00534330
• Device Catalogue Number: 3433
• Device Lot Number: 0028313849
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1