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

Model Number	M00570650
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
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.Date of event was approximated to (b)(6) 2020 as no specific event date was reported.(b)(4).The complainant indicated that the device was discarded and will not be returned for evaluation; therefore, a failure 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) 2020 that a wallflex biliary rx uncovered stent was to be implanted to treat a malignant stricture in the middle common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on an unknown date.According to the complainant, during the procedure, the guidewire would not advance through the stent even though the guidewire was wet and lubricated.Reportedly, it was noted that the catheter was kinked and the distal white olive tip of the delivery system was bent downward.The delivery system was removed and 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
• MDR Report Key: 10655114
• Report Number: 3005099803-2020-04506
• Device Sequence Number: 3146003
• Product Code: FGE
• UDI-Device Identifier: 08714729758150
• UDI-Public: 08714729758150
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

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: 07/08/2022
• Device Model Number: M00570650
• Device Catalogue Number: 7065
• Device Lot Number: 0025685504
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1