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

Model Number UNK540

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

Patient age at time of event: 18 years of age or older.(b)(4).Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).

Event Description

It was reported the hub separated from the catheter.A flexima¿ apdl drainage catheter was placed in the pleural cavity.The device drained successfully by way of wall section.Two days later the patient was brought back and the hub was noted to be separated from the catheter.A floppy guidewire was used to keep access while the catheter was removed and replaced with a new one.There were no patient complications, the patient was stable post procedure and has since been discharged from the hospital.

• 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: 7130583
• MDR Text Key: 95759931
• Report Number: 2134265-2017-12647
• 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: Health Professional
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• 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: 11/30/2017
• 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