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

Model Number	M00569660
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's exact age was not reported; however, the patient was reported to be over the age of 18.(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 february 11, 2022 that a wallstent biliary rx uncovered stent was to be implanted to treat a 10mm malignant obstruction in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6), 2022.Reportedly, the patient's anatomy was tortuous.During the procedure, there was difficulty advancing the delivery system through the stenosis.The stenosis was dilated and another attempt to cross the stenosis was made but was unsuccessful.The procedure was not completed due to device availability.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block a2: the patient's exact age was not reported; however, the patient was reported to be over the age of 18.Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: a wallstent biliary rx uncovered stent and delivery system were received for analysis.The stent was received undeployed.During visual inspection, the handle and the delivery system were inspected and no damages were found.The outer diameter of the tube was measured and found to be within specification.No issues with the stent and delivery system were noted.The reported event of delivery system difficult to cross lesion could not be not confirmed as this occurred during the procedure and could not be functionally/visually verified.The stent was returned undeployed and no damages were noted to the device during inspection.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 per the instructions for use (ifu) / product label.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), 2022 that a wallstent biliary rx uncovered stent was to be implanted to treat a 10mm malignant obstruction in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6), 2022.Reportedly, the patient's anatomy was tortuous.During the procedure, there was difficulty advancing the delivery system through the stenosis.The stenosis was dilated and another attempt to cross the stenosis was made but was unsuccessful.The procedure was not completed due to device availability.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

• Brand Name: WALLSTENT RX 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: 13660182
• Report Number: 3005099803-2022-01152
• Device Sequence Number: 1905900
• Product Code: FGE
• UDI-Device Identifier: 08714729296867
• UDI-Public: 08714729296867
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K012752
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022

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: 02/16/2022
• Device Model Number: M00569660
• Device Catalogue Number: 6966
• Device Lot Number: 0025875262
• 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: 02/11/2022
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2020
• 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
• Patient Sex: Unknown