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

Model Number M001271340

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Same case as medwatch report # mw5070033.It was reported that foreign matter was present in the catheter.An 8f flexima¿ apdl was selected for a left kidney procedure.The catheter was advanced into position and when the straightening dilator was removed it "stripped out".There was plastic in there that was not supposed to be there.A 9f pull away sheath was inserted over the existing catheter and the catheter was removed.The procedure was completed with a 10f x 25 cm flexima without further incident.No further patient complications were reported and the patient's status was fine.The device was saved and it was noticed that an extra piece of clear plastic was inside the catheter.

Manufacturer Narrative

The device was received for analysis with the flexible cannula stuck in the catheter.The flexible cannula and catheter were received without the proximal sections and its components look like both were cut at the same distance.A visual inspection of the device flexible cannula was performed and found to be severely kinked.Also, residues were found between the catheter and flexible cannula.No foreign matter was noted.Functional inspection of the device was performed.When attempting to remove the cannula, it could not be removed.Therefore, a transversal cut made to the tip of the catheter shows the flexible cannula was stuck located inside the profile tip.The dimension of the device was taken and the tip step was within specification.The catheter working length was not measured since its proximal section was not received and it looks like it was cut at 18cm from the coil.The cannula outer diameter and the metal cannula length were not measured due to its condition.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

It was further reported that it was noticed that a tube like piece was coming out of the hole in the pigtail.A 9f introducer dilator was used to place a new tube.A more intensive procedure was done to get the old tube out.There were no fragments migrated into the patient.The patient was discharged the same day.No further patient complications were reported.

Manufacturer Narrative

Ae or product problem, outcomes attrib.To ae, describe event or problem and type of reportable event updated.(b)(4).

Event Description

It was further reported that it was noticed that a tube like piece was coming out of the hole in the pigtail.A 9f introducer dilator was used to place a new tube.A more intensive procedure was done to get the old tube out.There were no fragments migrated into the patient.The patient was discharged the same day.No further patient complications were 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6664767
• MDR Text Key: 78379666
• Report Number: 2134265-2017-05895
• 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,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2019
• Device Model Number: M001271340
• Device Catalogue Number: 27-134
• Device Lot Number: 19880189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• 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): Required Intervention