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

Model Number M00569620

Device Problems Premature Activation (1484); Use of Device Problem (1670); Difficult to Advance (2920)

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

Event Date 12/04/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a wallstent biliary rx uncovered stent was to be implanted in the common bile duct to treat obstructive jaundice and pancreatitis with malignancy during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, there was an attempt to insert the stent percutaneously; however, it was not successful.The stent later fell off outside the patient and a drainage tube was implanted.The procedure was aborted due to device availability.The patient will be rescheduled for another procedure and was kept under observation to determine if another stent is needed.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: it was reported that the device was attempted to be inserted percutaneously.Per the ifu, "the delivery system is designed for endoscopic introduction into the biliary duct and may be inserted through the working channel of a therapeutic or diagnostic duodenoscope (minimum channel diameter 3.2 mm).".

Manufacturer Narrative

Block h6: imdrf device code a150103 captures the reportable event of stent prematurely deployed.

Manufacturer Narrative

Block h6: imdrf device code a150103 captures the reportable event of stent prematurely deployed.Block h10: a wallstent biliary stent and delivery system were received for analysis.The stent was received fully deployed and expanded.Visual examination of the returned device found the stainless-steel handle kinked.No other problems were noted with the stent and delivery system.The observed problem of stainless-steel handle kinked was likely due to factors encountered during the procedure.It may be that lesion characteristics, handling of the device and the technique used by the physician (force applied), limited the performance of the device and contributed to the observed problem.The reported event of stent premature deployment cannot be confirmed as this event occurred during the procedure and it is not possible to replicate in the laboratory of analysis.Based on the available information, there is not enough information to confirm the reported event of stent premature deployment; therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A labeling review was performed and, from the information available, this device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the device was attempted to be inserted percutaneously.Per the ifu, "the delivery system is designed for endoscopic introduction into the biliary duct and may be inserted through the working channel of a therapeutic or diagnostic duodenoscope (minimum channel diameter 3.2 mm).".

Event Description

It was reported to boston scientific corporation that a wallstent biliary rx uncovered stent was to be implanted in the common bile duct to treat obstructive jaundice and pancreatitis with malignancy during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, there was an attempt to insert the stent percutaneously; however, it was not successful.The stent later fell off outside the patient and a drainage tube was implanted.The procedure was aborted due to device availability.The patient will be rescheduled for another procedure and was kept under observation to determine if another stent is needed.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: it was reported that the device was attempted to be inserted percutaneously.Per the ifu, "the delivery system is designed for endoscopic introduction into the biliary duct and may be inserted through the working channel of a therapeutic or diagnostic duodenoscope (minimum channel diameter 3.2 mm).".

• Brand Name: WALLSTENT RX 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: 18394186
• MDR Text Key: 331666952
• Report Number: 3005099803-2023-06855
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K012752
• 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: 03/01/2024

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
• Device Operator: Health Professional
• Device Model Number: M00569620
• Device Catalogue Number: 6962
• Device Lot Number: 0032003557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2023
• 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
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 46 KG