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

Model Number	M00570720
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 november 10, 2020 that a wallflex biliary rx partially covered stent was implanted to treat a 4cm malignant stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed successfully; however, upon removal of the delivery system, it was noted that the delivery system was difficult to remove and the sheath buckled.After several attempts, the physician was able to remove the delivery system.The stent remains implanted and the procedure was completed.There were no patient complications reported as a result of this event.Note: a photo of the complaint device after the procedure was provided by the complainant and shows the sheath was buckled.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2020 that a wallflex biliary rx partially covered stent was implanted to treat a 4cm malignant stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6), 2020.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed successfully; however, upon removal of the delivery system, it was noted that the delivery system was difficult to remove and the sheath buckled.After several attempts, the physician was able to remove the delivery system.The stent remains implanted and the procedure was completed.There were no patient complications reported as a result of this event.Note: a photo of the complaint device after the procedure was provided by the complainant and shows the sheath was buckled.
Additional Manufacturer Narrative
Block h6: device problem code 1528 captures the reportable event of delivery system difficult to remove.Block h10: a wallflex biliary rx delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found the outer clear sheath was accordioned.The outer diameter (od) of the delivery system was measured and was found to be within specification.No other issues were noted to the device.The reported event of sheath buckled material was confirmed; however, the reported event of delivery system difficult to remove was not confirmed as it is not possible to replicate in the laboratory of analysis and the failure reported occured during the procedure.Taking all available information into consideration, the investigation concluded that the reported events were likely due to factors encountered during the procedure.It may be that the interaction of the device with the scope, the techniques used by the user and/or the anatomy of the patient, limited the performance of the device and contributed to the damage on the delivery system and caused difficulty in removing the delivery system.It is likely that the physician felt resistance and used force, resulting in the buckled delivery system and subsequently the delivery system was difficult to remove.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu) / product label.

• 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: 10936246
• Report Number: 3005099803-2020-05786
• Device Sequence Number: 19705398
• Product Code: FGE
• UDI-Device Identifier: 08714729759317
• UDI-Public: 08714729759317
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: 07/10/2021
• Device Model Number: M00570720
• Device Catalogue Number: 7072
• Device Lot Number: 0024092960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1