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

Model Number	M00570740
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, 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 partially covered stent was to be implanted in the common bile duct to treat a cholangiocarcinoma during a stent placement procedure performed on (b)(6) 2022.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, there was difficulty in advancing the delivery system through the lesion.The stent was successfully deployed; however, there was difficulty encountered during withdrawal of the delivery system through the deployed stent.The permalume cover of the stent was torn during the delivery system removal.Reportedly, the stent was too long for the patient's anatomy and the physician chose to remove and replace it.The stent was difficult to remove but was successfully removed from the patient with a snare.The procedure was completed with a smaller sized wallflex biliary partially covered stent.There were no patient complications as a result of this event.

• 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: 14147940
• Report Number: 3005099803-2022-02012
• Device Sequence Number: 2946169
• Product Code: FGE
• UDI-Device Identifier: 08714729759331
• UDI-Public: 08714729759331
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2022

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: 07/23/2023
• Device Model Number: M00570740
• Device Catalogue Number: 7074
• Device Lot Number: 0027719349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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 Sex: Unknown