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

Model Number	M00570640
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Injury (2348); Weight Changes (2607); No Code Available (3191)
Date of Event	05/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was reported by the patient.According to the patient, the ercp procedures were performed at (b)(6) and three different physicians were involved.The physicians were all from the (b)(6) clinic.The original stent placement was performed by dr.(b)(6).The first attempt to remove the stent was performed by dr.(b)(6).The 3 ercp procedures in (b)(6)2019 were performed by dr.(b)(6).(b)(4).The complainant indicated that the suspect device remains implanted 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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on october 07, 2019 that a wallflex biliary rx uncovered stent was implanted in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2019.Reportedly, the stent was initially implanted to treat suspected cancer; however, later determined the patient had autoimmune pancreatitis and did not have cancer.According to the complainant, as a result, the physician determined it was a mistake to have implanted an uncovered stent and decided to remove the stent.On (b)(6) 2019, an ercp was performed to remove the wallflex uncovered stent but the stent could not be removed.On (b)(6) 2019 a covered stent was placed inside the uncovered stent to facilitate stent removal.A second attempt to remove the uncovered stent was performed during an ercp on (b)(6) 2019; however, the physician was not able to find the covered stent so a longer stent was implanted inside.On (b)(6) 2019, during a third ercp to attempt to remove the uncovered stent the two covered stents were successfully removed but the uncovered stent was unable to be removed.The patient has reported experiencing many side effects, including weight loss of approximately 20 lbs.Reportedly, the patient received treatments after these ercps and is still in recovery.

• 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: 9267398
• Report Number: 3005099803-2019-05146
• Device Sequence Number: 16705162
• Product Code: FGE
• UDI-Device Identifier: 08714729756231
• UDI-Public: 08714729756231
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2019

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: 04/04/2021
• Device Model Number: M00570640
• Device Catalogue Number: 7064
• Device Lot Number: 0023598384
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 53