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

Model Number M00570740

Device Problems Entrapment of Device (1212); Premature Activation (1484); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2022

Event Type  malfunction  

Event Description

Note: this report pertains to one of two procedures involving one wallflex biliary stent.Refer to manufacturer report # 3005099803-2022-03915 for the associated procedure information.It was reported to boston scientific corporation on july 05, 2022 that a wallflex biliary rx partially covered stent was to be implanted to treat a malignancy common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2022.During the first procedure (the subject of this report), friction was met inside the scope and when the wallflex biliary stent was attempted to be used it was noted that there was no stent on the delivery system.The delivery system of the wallflex biliary stent was removed and the procedure was completed with another wallflex biliary stent without issue.However, after the scope was cleaned and attempted to be used in a second procedure (the subject of mfr.Report #3005099803-2022-03915), friction was noted while advancing an unknown catheter device through the working channel of the scope.A metal wire of a stent was then noted at the tip of the scope.It was determined that the wallflex biliary stent noted inside the scope was the same wallflex biliary stent from the first procedure which had deployed prematurely inside the scope during the first procedure.The wallflex biliary stent was removed together with the scope and another wallflex biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).The complainant indicated that the wallflex biliary stent was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to one of two procedures involving one wallflex biliary stent.Refer to manufacturer report # 3005099803-2022-03912 for the associated procedure information.It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex biliary rx partially covered stent was to be implanted to treat a malignancy common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2022.During the first procedure (the subject of this report), friction was met inside the scope and when the wallflex biliary stent was attempted to be used it was noted that there was no stent on the delivery system.The delivery system of the wallflex biliary stent was removed and the procedure was completed with another wallflex biliary stent without issue.However, after the scope was cleaned and attempted to be used in a second procedure (the subject of mfr.Report #3005099803-2022-03915), friction was noted while advancing an unknown catheter device through the working channel of the scope.A metal wire of a stent was then noted at the tip of the scope.It was determined that the wallflex biliary stent noted inside the scope was the same wallflex biliary stent from the first procedure which had deployed prematurely inside the scope during the first procedure.The wallflex biliary stent was removed together with the scope and another wallflex biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: medical device problem code a150103 captures the reportable event of wallflex biliary stent prematurely deployed inside the scope.Block h10: a wallflex biliary stent and delivery system were returned for analysis.The stent was received fully deployed.Visual examination was performed and it was found that the outer sheath was stretched out in the guidewire access sleeve (gas) section and the outer clear sheath was kinked.A dimensional inspection of the outer clear and blue sheath was performed and it was found within specification.No other issues were noted to the stent and delivery system.The damages noted to the delivery system were most likely due to procedural factors encountered during the procedure.It may be that handling and excessive manipulation of the device without enough care could have induced the defect found.Demonstrating excessive force during handling/ usage against significant resistance could result to kinking of the outer clear sheath and stretching of the outer sheath at the guidewire access sleeve (gas) section.The reported event of stent premature deployment, device difficult to advance and device entrapment could not be confirmed; these failures occurred during the procedure, therefore, it could not be functionally/visually verified.Based on the available information, there is no indication of what the customer reported because the stent was returned completely deployed.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A product labeling review identified that the device was used per the directions for use (dfu) / product label.

• Brand Name: WALLFLEX BILIARY
• Type of Device: 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: 15094514
• MDR Text Key: 304221681
• Report Number: 3005099803-2022-03912
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729759331
• UDI-Public: 08714729759331
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K140630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2024
• Device Model Number: M00570740
• Device Catalogue Number: 7074
• Device Lot Number: 0028812080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1