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

Model Number	M00570650
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on april 16, 2021 that a wallflex biliary rx uncovered stent was to be implanted to treat a malignant stricture in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the metal stent was kinked when it was attempted to be deployed.Reportedly, the stent was removed from the patient partially deployed on the delivery system and another wallflex biliary stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: medical device problem code a0406 captures the reportable event of stent kinked (deformed).Block h10: a wallflex biliary rx uncovered stent and delivery system were received for analysis.The stent was received fully covered and undeployed.A visual examination of the returned device found the outer sheath, inner sheath and yellow jacket kinked.A functional inspection was performed and the stent was deployed by actuating the delivery system (slide the handle back along the stainless steel tube).No other issues were noted to the stent and delivery system.The reported events of stent partially deployed and stent material deformation cannot be confirmed as the stent was returned fully covered and undeployed as well as no damages were noted to the stent.Taking all available information into consideration, the investigation concluded that the reported events and observed failures may have been related to procedural factors.The kinks in the device could have caused the physician to perceive the stent as deformed; however, after the deployment during the functional inspection the stent was inspected and no damages were noted.It may be that the patient's tortuous anatomy could have caused the physician to feel resistance during the attempted deployment, limited the performance of the device and contributed to the reported events and the observed failures.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to patient condition.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex biliary rx uncovered stent was to be implanted to treat a malignant stricture in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the metal stent was kinked when it was attempted to be deployed.Reportedly, the stent was removed from the patient partially deployed on the delivery system and another wallflex biliary stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 11793772
• Report Number: 3005099803-2021-02068
• Device Sequence Number: 3921734
• Product Code: FGE
• UDI-Device Identifier: 08714729758150
• UDI-Public: 08714729758150
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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: 06/08/2022
• Device Model Number: M00570650
• Device Catalogue Number: 7065
• Device Lot Number: 0025571983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 53