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

Model Number UNK540

Device Problems Migration or Expulsion of Device (1395); Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

Patient Problems Abscess (1690); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Myocardial Infarction (1969); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Literature citation: prashant kedia, md,"endoscopic gallbladder drainage compared with percutaneous drainage", volume 82, no.6 : published: 2015.(b)(4).Device evaluated by manufacturer: the device was not received for analysis.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as mdr id# 2134265-2017-10215 it was reported via a journal article that the patients experienced complications post procedure.The study objective was to compare the short- and long-term outcomes of percutaneous gallbladder drainage (pgbd).For treatment, pgbd was performed using an 8f or 10f all purpose drainage catheter.Patients were routinely brought back after 6 to 8 weeks for catheter check under fluoroscopy and removal.Adverse events in patients that received pgbd treatment included catheter dislodgment, catheter migration, catheter related pain, catheter occlusion, cellulitis, perihepatic abscess, intraperitoneal bleeding, cholecystitis, cholangitis, myocardial infarction, pneumothorax and hemobilia, bile leak and a mechanical failure during one procedure.

• 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 (Section G): 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: 6966527
• MDR Text Key: 89914838
• Report Number: 2134265-2017-10214
• Device Sequence Number: 1
• Product Code: FFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other