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

Model Number	M00570630
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 uncovered stent was to be implanted to treat an 80mm lesion obstructing the common bile duct secondary to pancreatic cancer during a stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not dilated prior to stent placement.During the procedure, the outer sheath broke and inner sheath detached during attempted deployment.The physician pushed out the detached inner sheath from the scope using another catheter into the patient and removed the inner sheath using forceps.The stent was removed from the patient partially deployed on the delivery system.The procedure was completed with another wallflex biliary stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a0501 captures the reportable event of inner sheath detached.Block h10: a wallflex biliary uncovered stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual inspection found the device returned in two sections.The device was detached in the guidewire access sleeve (gas) section.The outer clear sheath was accordioned and the inner shaft was broken in two sections.No other issues with the stent and delivery system were noted.The reported events of sheath break and inner shaft/sheath detachment of device or device component were confirmed; however, the reported event of stent partially deployed could not be confirmed as the stent was received fully covered and undeployed.The investigation concluded that the reported events and the observed failure were most likely due to procedural factors encountered during the procedure.It may be that handling of the device, the techniques used by the user, the characteristics of the lesion and the normal procedural difficulties, limited the performance of the device and contributed to the detachment of the outer and inner sheath from the delivery system.The outer sheath and the inner sheath being broken could have resulted in the stent being unable to deploy during the procedure.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 on november 01, 2021 that a wallflex biliary rx uncovered stent was to be implanted to treat an 80mm lesion obstructing the common bile duct secondary to pancreatic cancer during a stent placement procedure performed on (b)(6), 2021.Reportedly, the patient's anatomy was not dilated prior to stent placement.During the procedure, the outer sheath broke and inner sheath detached during attempted deployment.The physician pushed out the detached inner sheath from the scope using another catheter into the patient and removed the inner sheath using forceps.The stent was removed from the patient partially deployed on the delivery system.The procedure was completed with another wallflex biliary stent.There were no patient complications reported as a result of this event.

• 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: 12852135
• Report Number: 3005099803-2021-06016
• Device Sequence Number: 12032489
• Product Code: FGE
• UDI-Device Identifier: 08714729759270
• UDI-Public: 08714729759270
• 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): 04/20/2022

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: 03/11/2023
• Device Model Number: M00570630
• Device Catalogue Number: 7063
• Device Lot Number: 0026954727
• 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: 11/01/2021
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: American Indian Or Alaskan Native