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

Model Number	M00570520
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A wallflex biliary rx covered stent was received for analysis; the delivery system was not returned.The stent was returned fully deployed.Visual examination of the returned device found the stent cover (holes) was damaged.The stent was deformed and the stent retrieval loop was damaged.No other issues were noted to the stent.The reported event of stent partially deployed was not confirmed as the stent was received fully deployed.Taking all available information into consideration, the investigation concluded that the reported event and the observed failures were likely due to procedural or anatomical factors encountered during procedure.It may be that how the device was handled or manipulated, limited the performance of the device and contributed to the stent deployment partial, stent damaged and deformation and the stent cover damaged.Manipulation of the device during use can lead to the deformation of the stent and difficulties releasing the stent.Continued attempts to release the stent can damage the stent cover and the retriever loop.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.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 that a wallflex biliary rx covered stent was to be implanted to treat a biliary tract tumor in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent could not be deployed.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 as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed a mdr-reportable event based on investigation results which revealed that the stent cover and stent retrieval loop were damaged and the stent was deformed.

• 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: 12293723
• Report Number: 3005099803-2021-03986
• Device Sequence Number: 14244318
• Product Code: FGE
• UDI-Device Identifier: 08714729764908
• UDI-Public: 08714729764908
• 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
• Report Date (Section B): 08/09/2021

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: 12/11/2022
• Device Model Number: M00570520
• Device Catalogue Number: 7052
• Device Lot Number: 0026505451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 65