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

Model Number	M00570660
Medical Device Problem Codes	Defective Device (2588); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: approximated based on the date the manufacturer became aware of the event.(b)(4).The initial reporter's address is (b)(6).A wallflex biliary rx delivery system was received for analysis; the stent was not returned.Visual examination was performed and found one section of the inner sheath and the yellow jacket detached.The outer clear sheath was kinked and accordioned.The guidewire access sleeve (gas) ramp was lifted.The inner sheath was misaligned with the outer sheath.No other problems with the delivery system were noted.Product analysis confirmed the reported event of device damaged/defective.The inner sheath was detached, the outer sheath was kinked and accordioned.The observed failures were most likely due to procedural factors encountered during the procedure.It may be that 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.Therefore, contributing to inner sheath detached.A review and analysis of all available information indicated the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex biliary uncovered stent was used during a procedure performed on an unknown date.During the procedure, the wallflex biliary stent was noted to be defective.Note: no further information has been obtained despite good faith efforts.This event has been deemed an mdr reportable event based on the investigation results which revealed that the inner sheath of the wallflex biliary stent was detached.

• 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: 15429381
• Report Number: 3005099803-2022-05204
• Device Sequence Number: 7511308
• Product Code: FGE
• UDI-Device Identifier: 08714729759287
• UDI-Public: 08714729759287
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2022

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: 08/28/2022
• Device Model Number: M00570660
• Device Catalogue Number: 7066
• Device Lot Number: 0025930656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown