MAUDE Adverse Event Report: COVIDIEN PALINDROME PRECISION 23CM SPORTPACK; DIALYSIS CATHETER

Model Number 8888123404P

Device Problem Aspiration Issue (2883)

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

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 11/4/2016.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a dialysis catheter.The customer reports the doctor put two of these catheters in and both would not aspirate on the arterial lumen after it was placed.He had to replace the catheter with angio dynamic duraflow.The patient status is fine.

Manufacturer Narrative

This event was originally reported as one patient event with two catheters.Additional information was received and this specific report involved one patient with one catheter.The event description has been updated.The customer reports the doctor put the catheter in and it would not aspirate on the arterial lumen after it was placed.He had to replace the catheter with angio dynamic duraflow.The patient status is fine.

Manufacturer Narrative

Submit date: 03/04/2017.As no lot number was identified, a manufacturing device history record (dhr) review or product/process changes review for the involved lot number could not be performed.However, all dhrs are reviewed for accuracy prior to product release.The product sample was returned to the manufacturing site for review, it consisted in a palindrome catheter.The sample came inside a plastic bag that is not the original of the product.During visual inspection, the cuff of the catheter presents signs of use (remains of blood).In order to confirm the defect reported, a new stylet were passed through both extensions; as result the stylet passed easily through the lumens.As part of the evaluation, the sample was flushed and did not present any problem in the extension; the water passed easily through the lumens.Therefore the defect was not confirmed.Based to the evaluation of the sample the catheter did not reveal any problem related to the reported condition.It is possible considering the device dueling time, that there is a patient related condition (catheter placement in the vessel or internal kink) that may explain the reported condition.Based on the available information, it can be concluded that product was manufactured according to specifications and the most probable root cause can be considered as a patient related condition / catheter placement.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% visual inspection, and visual acceptance sampling are performed in the plant) are in place to prevent nonconforming product from leaving the manufacturing operations.No additional actions are required.This complaint will be used for tracking and trending purposes.

• Brand Name: PALINDROME PRECISION 23CM SPORTPACK
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN MANUFACTURING SOLUTIONS SA; edificio 820 calle #2; zona franca coyol; alajuela ; CS
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6082158
• MDR Text Key: 59599005
• Report Number: 3009211636-2016-00449
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888123404P
• Device Catalogue Number: 8888123404P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1