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

Model Number	M00570610
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The wallflex biliary stent has not been received for analysis.Upon receipt and completion of the device 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 on (b)(6) 2022 that a wallflex biliary rx uncovered stent was to be implanted in the bile duct to treat a 3.5cm biliary obstruction during a stent placement procedure performed on (b)(6) 2022.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the wallflex biliary stent deployed prematurely and 2/3 of the stent was still inside the scope.The wallflex biliary stent was removed together within the scope and another wallflex biliary stent was implanted to complete 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 on june 22, 2022 that a wallflex biliary rx uncovered stent was to be implanted in the bile duct to treat a 3.5cm biliary obstruction during a stent placement procedure performed on (b)(6) 2022.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the wallflex biliary stent deployed prematurely and 2/3 of the stent was still inside the scope.The wallflex biliary stent was removed together within the scope and another wallflex biliary stent was implanted to complete 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 h6: medical device problem code a150103 captures the reportable event of wallflex biliary stent deployed prematurely.Block h10: the wallflex biliary delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found the outer clear sheath was accordioned near the tip.No other issues were noted to the delivery system.The damage observed to the delivery system was most likely due to procedural factors.It may be that the lesion characteristics, handling of the device, the technique used by the user, and/or normal procedural difficulties encountered during the procedure, limited the performance of the device, and contributed to outer sheath accordioned.However, the reported event of stent prematurely deployed could not be confirmed.This problem occurred during the procedure, and it is not possible to replicate in the laboratory of analysis.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.

• Brand Name: WALLFLEX 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; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15018064
• Report Number: 3005099803-2022-03817
• Device Sequence Number: 6753332
• Product Code: FGE
• UDI-Device Identifier: 08714729759256
• UDI-Public: 08714729759256
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140630
• 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): 10/24/2022

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: 07/14/2023
• Device Model Number: M00570610
• Device Catalogue Number: 7061
• Device Lot Number: 0027661760
• 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: 06/22/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 60 KG