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

Model Number	M00570890
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the stent remains implanted and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, 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 implanted in the common bile duct to treat a malignant, extrinsic pancreatic mass during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on an unknown date.Reportedly, the patient's anatomy was tortuous and was not dilated prior to the stent placement procedure.Five days post stent placement, the patient was admitted to the intensive care unit with cholangitis.Imaging was performed, and it was noted that the stent did not fully expand.Reintervention via ercp was performed and two plastic stents were implanted within the wallflex biliary stent to allow for biliary drainage.Reportedly, the physician was comfortable leaving the wallflex biliary uncovered stent implanted.The patient was reported to be fully recovered and the patient's current condition was reported to be fine.

• 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: 13176714
• Report Number: 3005099803-2021-08148
• Device Sequence Number: 4562607
• Product Code: FGE
• UDI-Device Identifier: 08714729765332
• UDI-Public: 08714729765332
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2022

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 Model Number: M00570890
• Device Catalogue Number: 7089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown