MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA APDL; TUBE, DRAINAGE, SUPRAPUBIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 08/12/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: publication date used.Initial reporter facility name: (b)(6).Devrim akinci, emre unal, turkmen turan ciftci, sara kyendyebai, osman abbasoglu, okan akhan.Endobiliary radiofrequency ablation in the percutaneous management of refractory benign bilioenteric anastomosis strictures.Ajr 2019; 212:w83 through w91.

Event Description

It was reported via a journal article that cholangitis occurred.Twenty-one patients (11 men) with a mean age of 47.9 years (range, 26 to 73 years) underwent percutaneous balloon dilatation and long-term drainage for benign bilioenteric anastomosis strictures.Endobiliary rfa was performed in six patients (four men; mean age, 53.1 years; range, 43 to 63 years) whose strictures did not respond to balloon dilatation and long-term drainage.The presenting symptoms of the 21 patients were jaundice (n = 21), right upper quadrant pain (n = 19), pruritus (n = 17), and cholangitis (n = 1 5).T he patients had undergone cholecystectomy (n = 11; 52.4%), choledochal cyst excision (n = 3; 14.3%), right hepatic lobectomy (n = 3; 14.3%), whipple surgery (n = 3; 14.3%), and kasai procedure (n = 1; 4.8%), which resulted in hepaticojejunostomy (n = 17; 81.0%), choledochojejunostomy (n =3; 14.3%), and choledochoduodenostomy (n = 1; 4.8%).The mean interval between the surgery and development of symptoms was 1384 days (range, 4 to 7592 days).In the follow-up period, seven patients (33%) with catheters developed cholangitis symptoms due to catheter-related complications, and they were managed with catheter exchange and antibiotic therapy.There were no major complications.

• Brand Name: FLEXIMA APDL
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC; 2546 first street; propark, el coyol ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14879817
• MDR Text Key: 295116332
• Report Number: 2134265-2022-07482
• Device Sequence Number: 1
• Product Code: FFA
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention