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

Model Number M001271340

Device Problems Partial Blockage (1065); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.(b)(4).

Event Description

It was reported that a foreign matter was noted within the catheter.A flexima apdl was selected for treatment.During preparation, outside of the patient, a guidewire was threaded into the stylet of the device when it was unable to pass through the middle portion.Furthermore, it was then noted that a blue spec, which appeared to be a catheter material, was inside of the stylet.The device did not enter into the patient's body.The procedure was completed with a different device.No patient complications reported.

• Brand Name: FLEXIMA¿ APDL
• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5224506
• MDR Text Key: 31450529
• Report Number: 2134265-2015-08050
• 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: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: M001271340
• Device Catalogue Number: 27-134
• Device Lot Number: 0018137114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2015
• 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