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

Model Number	M00570740
Medical Device Problem Codes	Use of Device Problem (1670); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex biliary rx partially covered stent was implanted to treat a 4-5 cm cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement procedure.During the procedure, the physician did not know how to deploy the stent correctly and the stent was deployed in an incorrect location.The stent remains implanted 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 following the procedure was reported to be stable.Note: it was reported that the physician did not know how to deploy the stent correctly.Per the dfu, "the wallflex biliary rx partially covered stent system should only be used by or under the supervision of physicians thoroughly trained in biliary prosthesis placement.A thorough understanding of the technical principles, clinical applications, and risks associated with this procedure is necessary before using this device.".
Additional Manufacturer Narrative
Block h6: medical device problem code a1502 captures the reportable event of stent positioning issue.Block h10: a wallflex biliary delivery system was received for analysis; the stent was not returned.Visual examination was performed and found the outer clear sheath was kinked.No other issues were noted to the delivery system.The reported event of stent positioning issue could not be confirmed; the stent was not returned, the reported event occurred during the procedure and could not be functionally/ visually verified.The damage noted to the outer sheath was most likely due to procedural factors encountered during the procedure.It may be how the device was handled or manipulated during the procedure could contribute to outer clear sheath kinked.A labelling 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 physician did not know how to deploy the stent correctly.The ifu states " the wallflex biliary rx partially covered stent system should only be used by or under the supervision of physicians thoroughly trained in biliary prosthesis placement.A thorough understanding of the technical principles, clinical applications, and risks associated with this procedure is necessary before using this device".Furthermore, stent misplacement is noted within the ifu as a potential complications associated with the use of this device.The reported adverse event is known and documented in the labeling.Therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk of device.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 partially covered stent was implanted to treat a 4-5 cm cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement procedure.During the procedure, the physician did not know how to deploy the stent correctly and the stent was deployed in an incorrect location.The stent remains implanted 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 following the procedure was reported to be stable.Note: it was reported that the physician did not know how to deploy the stent correctly.Per the dfu, "the wallflex biliary rx partially covered stent system should only be used by or under the supervision of physicians thoroughly trained in biliary prosthesis placement.A thorough understanding of the technical principles, clinical applications, and risks associated with this procedure is necessary before using this device.".

• 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: 13026652
• Report Number: 3005099803-2021-07824
• Device Sequence Number: 17503408
• Product Code: FGE
• UDI-Device Identifier: 08714729759331
• UDI-Public: 08714729759331
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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: 04/07/2023
• Device Model Number: M00570740
• Device Catalogue Number: 7074
• Device Lot Number: 0027095510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2021
• 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
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 61 KG