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

Model Number M001271380

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Age at time of event: 18 years or older.Device evaluated by mfr: the device was returned for analysis.The device was returned with the metal cannula loaded in the catheter.Also the suture was received broken.A mandrel 0.038 inches was inserted through the stent, it passed properly without resistance.The cannula od was measured at three locations and the metal cannula od's were found within specification.No other issue or defects noted on the analysis of the returned device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable based on device analysis completed on 21apr2016.It was reported that the inability to straighten the stiffening cannula occurred.During a procedure, a flexima apdl drainage catheter was selected for use.However, the stiffening canula was unable to be straighten.The procedure was completed with a different device.No patient complications reported and the patient's condition is fine.However, device analysis revealed that the suture was broken.

Manufacturer Narrative

Device evaluated by mfr: the metal cannula was noted to be kinked.(b)(4).

Event Description

Reportable based on device analysis completed on 21apr2016.It was reported that the inability to straighten the stiffening cannula occurred.During a procedure, a flexima¿ apdl drainage catheter was selected for use.However, the stiffening canula was unable to be straighten.The procedure was completed with a different device.No patient complications reported and the patient's condition is fine.However, device analysis revealed that the suture was broken.

• 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: 5662354
• MDR Text Key: 45418089
• Report Number: 2134265-2016-04118
• 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,Followup
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2018
• Device Model Number: M001271380
• Device Catalogue Number: 27-138
• Device Lot Number: 18495185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2015
• 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