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

Model Number	M00570500
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter's city, province, and postal code: (b)(6).Initial reporter's fax number: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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 covered stent was to be implanted to treat a benign stenosis in the ampulla 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 not dilated prior to stent placement.During the procedure, the stent was able to be deployed; however, it was noted that the stent was incorrectly placed near the hepatic ducts.The stent was removed with biopsy forceps and another wallflex biliary stent was implanted to complete the procedure.There were no patient complications as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: (b)(6).Block h6: medical device problem code a1502 captures the reportable event of stent positioning issue.Block h10: a wallflex biliary rx covered stent and delivery system were received for analysis.The stent was received completely deployed.Visual examination found no damages to the stent and delivery system.The reported event of stent positioning issue could not be confirmed; the reported event occurred during the procedure and is not possible to replicate in the laboratory of analysis.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Additionally, stent misplacement is noted within the ifu as a potential complications associated with the use of this device.The reported event is known and documented in the manufacturer's 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 december 19, 2021 that a wallflex biliary rx covered stent was to be implanted to treat a benign stenosis in the ampulla 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 not dilated prior to stent placement.During the procedure, the stent was able to be deployed; however, it was noted that the stent was incorrectly placed near the hepatic ducts.The stent was removed with biopsy forceps and another wallflex biliary stent was implanted to complete the procedure.There were no patient complications as a result of this event.The patient 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
• 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: 13224789
• Report Number: 3005099803-2021-08219
• Device Sequence Number: 11803467
• Product Code: FGE
• UDI-Device Identifier: 08714729764885
• UDI-Public: 08714729764885
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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 Expiration Date: 05/15/2022
• Device Model Number: M00570500
• Device Catalogue Number: 7050
• Device Lot Number: 0025516812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2021
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2020
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: White