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

Model Number	M00570650
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure 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) 2019 that a wallflex biliary rx uncovered stent was to be used during a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the stent was released inside the patient.During catheter removal, the delivery system got stuck in the distal part of the stent, and the stent was pulled out together with the delivery system.Reportedly, the stent was noted to be bent.There were no patient complications reported as a result of this event.The patient's condition was reported to be fine.
Additional Manufacturer Narrative
Problem code 1528 captures the reportable event of delivery system difficult to remove.Problem code 2976 captures the reportable event of stent damaged (bent).A deployed wallflex biliary rx uncovered stent and delivery system were returned for analysis.Visual examination of the returned device found the clear outer sheath at the distal end and at the yellow jacket were kinked.The inner shaft was completely detached from the device.The stent was kinked and a coffee-colored foreign object was found around the stent that appears to be old and worn down.No other issues with the device were noted.The complainant confirmed the correct device was returned for analysis.The complainant did not know what the foreign object might be, but it was reported that the patient does not have any history of other previous devices.It is unclear if the coffee-colored object found around the stent was in the body or in the scope.The kink in the stent may have been due to excessive force that was applied during removal of the stent.The damages identified on the returned delivery system were consistent with the application of excessive force when resistance was encountered during delivery system withdrawal.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2019 that a wallflex biliary rx uncovered stent was to be used during a procedure performed on (b)(6), 2019.According to the complainant, during the procedure, the stent was released inside the patient.During catheter removal, the delivery system got stuck in the distal part of the stent, and the stent was pulled out together with the delivery system.Reportedly, the stent was noted to be bent.There were no patient complications reported as a result of this event.The patient's condition was reported to be fine.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8371474
• Report Number: 3005099803-2019-00864
• Device Sequence Number: 13852665
• Product Code: FGE
• UDI-Device Identifier: 08714729758150
• UDI-Public: 08714729758150
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2019

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: 08/16/2020
• Device Model Number: M00570650
• Device Catalogue Number: 7065
• Device Lot Number: 0022527556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1