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

Model Number M001271800

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id: 2134265-2018-07013.It was reported that foreign matter was observed on the device.Two 10.3 flexima drainage catheters were selected for use.During the procedure, the physician put two flexima catheters in the patient; however, it was noted that both catheters leaked around the hub.It was further noted that there was like a small piece of a thread coming out of the catheter hub where the physician thought it was leaking.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.

Manufacturer Narrative

Updated device evaluated by mfr., eval summary attached, method codes, result codes and conclusion codes.Device evaluated by mfr: the device was returned for analysis.Visual inspection revealed that the catheter returned was cut at 10cm from the proximal end.No foreign matter were noted in the returned hub.Only the suture string was observed at stopcock of the hub and the hub looks under good conditions without evidence of damages or anomalies.Water was injected using a syringe through the hub and no leaks were found.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-07013.It was reported that foreign matter was observed on the device.Two 10.3 flexima¿ drainage catheters were selected for use.During the procedure, the physician put two flexima¿ catheters in the patient; however, it was noted that both catheters leaked around the hub.It was further noted that there was like a small piece of a thread coming out of the catheter hub where the physician thought it was leaking.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.

• Brand Name: FLEXIMA¿
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7726671
• MDR Text Key: 115367019
• Report Number: 2134265-2018-07014
• 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
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: M001271800
• Device Catalogue Number: 27-180
• Device Lot Number: 22056318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Date Manufacturer Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1