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

Model Number	M00570600
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Inflammation (1932); Jaundice (2187)
Date of Event	02/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device 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, the supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on september 11, 2018 that a wallflex biliary rx uncovered stent was implanted in the bile duct on (b)(6) 2016, as part of the e7034 wallflex biliary preop drainage natx clinical trial.According to the complainant, on (b)(4) 2016, baseline liver function tests were taken.Assessment of biliary obstructive symptoms (abos) was conducted and the following symptoms were reported: dark urine, jaundice, nausea/ vomiting, and itching.A 2.6 cm adenocarcinomic tumor was found in the head of the pancreas.On (b)(6) 2016, the patient underwent a study stent placement in an inpatient setting.A biliary sphincterotomy was performed during the stent placement procedure.Prophylactic antibiotics were administered.The 8mm x 40 mm wallflex biliary uncovered stent was placed in a satisfactory manner.On (b)(6) 2016, the patient experienced cholangitis and was hospitalized on (b)(6) 2016.On (b)(6) 2016, a naso-biliary drain was placed.According to the complainant, there were no visible abnormalities such as occlusion or migration of the stent but the cholangitis was also deemed "obstructive cholangitis due to study stent occlusion".It was also reported that "jaundice progressed even after fcsems, so we removed fcsems".On (b)(6) 2016, the patient underwent the curative intent surgery.Patient's karnofsky score was 70.No biliary obstructive symptoms were reported.Prophylactic antibiotics were administered.Reportedly, the tumor was confirmed resectable.The patient underwent a whipple procedure and the study stent was removed during the surgery before resecting the tumor.It was reported that the tumor was 2.5 cm.The patient was discharged on (b)(6) 2016.Reportedly, the patient completed the study on (b)(6) 2016, 30 days post surgery.Karnofsky score was 90.No biliary obstructive symptoms were reported.

• 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: 7935939
• Report Number: 3005099803-2018-60694
• Device Sequence Number: 19210855
• Product Code: FGE
• UDI-Device Identifier: 08714729759249
• UDI-Public: 08714729759249
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2018

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: 09/22/2017
• Device Model Number: M00570600
• Device Catalogue Number: 56429
• Device Lot Number: 0018434921
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 10/04/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 54 YR