MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) FLEXIMA CATHETER; TUBE, DRAINAGE, SUPRAPUBIC

Model Number UNK540

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Hematuria (2558)

Event Type  Injury  

Manufacturer Narrative

Updated: brand name, common device name, product code, upn, mdr contact, contact office name, pma# or 510k#.(b)(4).

Event Description

Boston scientific corporation became aware of adverse patient events through the article "efficacy and complications of urinary drainage procedures in idiopathic retroperitoneal fibrosis complicated by extrinsic ureteral obstruction." written by s.Mertens,et al.According to the literature, the aim of the study was to determine the efficacy and complications of urinary drainage procedures in patients with idiopathic retroperitoneal fibrosis complicated by ureteral obstruction, as it is recommended therapeutic option to be used together with intraureteral stent placement for this medical problem.As the implementation of the use of urinary drainage increasing, there is a need for safety and efficacy data from current clinical practice.The study took place between january 2002 and april 2010 and included 30 male patients involving 44 obstructed urinary cases, who were introduced to boston scientific flexima ureteral catheter and non-bsc stents.It is unknown if the adverse events were related to the use of the boston scientific flexima ureteral catheter; however, the complications were reported to be: 21 incidents of infectious problems related to the urinary tract occurred in 11 patients.Of these, 12 episodes in nine patients were diagnosed as acute pyelonephritis; three of these episodes in two patients were complicated by urosepsis.Other complications were bleeding requiring transfusion, transient hematuria, inflammation of the skin at the catheter exit site, and the effect of this external collecting device on individual emotional and social well-being.Tamoxifen, immunosuppressants, or both therapy were used during the indwelling period of external and internal urinary drainage procedures.The article did not provide any further information regarding these patients.If any additional information is received, a supplemental report will be filed.

• Brand Name: FLEXIMA CATHETER
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7247798
• MDR Text Key: 99221423
• Report Number: 2134265-2018-00275
• Device Sequence Number: 1
• Product Code: FFA
• Combination Product (y/n): N
• PMA/PMN Number: K944290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNK540
• Date Manufacturer Received: 01/09/2018
• Type of Device Usage: N
• Patient Sequence Number: 1