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

Model Number	M00570530
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was used for stricture during an endoscopic retrograde cholangiopancreatography procedure (ercp) procedure performed on (b)(6) , 2024.During the procedure, a severe stenosis in the common bile duct (cbd) was treated by dilating the area with a hurricane balloon.A wallflex stent was then deployed across the stenosis, but the proximal portion of the stent remained crimped on the internal stent catheter.Despite attempts to pass another wire and wait for radial expansion, the stent remained stuck.When the physician tried to remove the catheter with considerable force, the catheter tip broke off and lodged in the stent, as confirmed by fluoroscopy.The catheter was removed.On (b)(6) 2024, a second procedure was scheduled, and the lodge tip was retrieved.The procedure was completed with this device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.Imdrf device code a0406 captures the reportable event of stent material deformation.Imdrf impact code f2202 is being used to capture the additional endoscopic procedure to remove the detached tip.
Additional Manufacturer Narrative
Blocks b5, d6a (implant date), e1 (initial reporter's phone number, h6 (patient code and device code) have been corrected.Block h6: imdrf device code a0501 captures the reportable event of inner sheath detached.Imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Imdrf impact code f2202 is being used to capture the additional endoscopic procedure to remove the detached inner sheath.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx covered stent was implanted in the common bile duct to treat a severe stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.Reportedly, the patient's anatomy was dilated prior to stent placement.During the procedure, the stent was deployed; however, the proximal portion of the stent remained crimped on the tip of the internal stent catheter.Despite attempts to pass another wire and wait for radial expansion, the stent remained stuck.When the physician attempted to remove the catheter with considerable force, the inner sheath broke off and became lodged in the stent, as confirmed by fluoroscopy.The catheter was removed, the stent remained implanted, and the procedure was completed.On (b)(6) 2024, a second procedure was performed, during which the detached inner sheath was successfully retrieved.Note: a photo of the complaint device was provided by the complainant showing the inner sheath was detached, the outer sheath was kinked and damaged.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of inner sheath detached.Imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Imdrf impact code f2202 is being used to capture the additional endoscopic procedure to remove the detached inner sheath.Block h11: only the inner sheath and the yellow jacket of the wallflex biliary delivery system were received for analysis; the stent and the rest of the delivery system were not returned.A visual examination revealed that the inner sheath was kinked, and no other damage was noted on the device.Product analysis confirmed the reported event of the inner sheath detaching.However, the reported event of the delivery system being difficult to remove could not be confirmed, as the problem occurred during the procedure and could not be replicated in the laboratory.It is most likely that procedural factors encountered during the operation limited the device's performance and contributed to the separation and kinking of the inner sheath.Factors such as the lesion's characteristics, the handling of the device, the physician's technique, and the amount of force applied during use may have led to the observed damage.Therefore, a review and analysis of all available information indicate that the most probable cause is an adverse event related to the procedure.A device history record (dhr) review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots involved in the complaint, but no lots were found.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx covered stent was implanted in the common bile duct to treat a severe stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.Reportedly, the patient's anatomy was dilated prior to stent placement.During the procedure, the stent was deployed; however, the proximal portion of the stent remained crimped on the tip of the internal stent catheter.Despite attempts to pass another wire and wait for radial expansion, the stent remained stuck.When the physician attempted to remove the catheter with considerable force, the inner sheath broke off and became lodged in the stent, as confirmed by fluoroscopy.The catheter was removed, the stent remained implanted, and the procedure was completed.On (b)(6) 2024, a second procedure was performed, during which the detached inner sheath was successfully retrieved.Note: a photo of the complaint device was provided by the complainant showing the inner sheath was detached, the outer sheath was kinked and damaged.

• 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: 20277840
• Report Number: 3005099803-2024-04515
• Device Sequence Number: 12757330
• Product Code: FGE
• UDI-Device Identifier: 08714729764915
• UDI-Public: 08714729764915
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2024

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 Model Number: M00570530
• Device Catalogue Number: M00570530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 09/26/2024; 11/11/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/21/2024; 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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