MAUDE Adverse Event Report: COVIDIEN MANUF. SOLUTIONS SA PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED, COATED

Model Number 8888145043P

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter.The customer states once the catheter was implanted and after having removed the metal guide, the vena trac was withdrawn; the first without a problem.The second, when removed, broke at the beginning of the extensions of the catheter leaving the rest of the venatrack in the interior, so it was necessary to replace the catheter.

Manufacturer Narrative

A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhrs are reviewed for accuracy prior to product release.The physical sample involved in the reported incident was not returned for evaluation.One photo was provided by the customer.Visual evaluation of this photo was performed and it was observed that the catheter was inside the patient.Also, in this picture, it was observed one stylet was broken and showed signs of manipulation.As part of the testing, the complaints technician tried to replicate the issue by trying to remove the stylet when it was still attached to the guide wire.This caused a force on the arterial lumen stylet that causes it to break similar in appearance to the reported issue.An ishikawa diagram was used to determine the potential causes for this event.According to the photo evaluation, the reported condition was identified and con firmed.A manufacturing issue could not be related to the reported condition per the available information.The most probable cause was identified as customer misuse, inadequate manipulation of the components.No triggers or trends were identified and no harm was reported in this complaint therefore further corrective and preventive actions (capa) are not required at this moment.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 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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states once the catheter was implanted and after having removed the metal guide, the vena trac was withdrawn; the first without a problem.The second, when removed, broke at the beginning of the extensions of the catheter leaving the rest of the venatrack in the interior, so it was necessary to do the procedure again and to do the replacement of the catheter.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED, COATED
• Manufacturer (Section D): COVIDIEN MANUF. SOLUTIONS SA; edificio 820 calle#2; zona franca coyol; alajuela 20101
• Manufacturer (Section G): COVIDIEN MANUF. SOLUTIONS SA; edificio 820 calle#2; zona franca coyol; alajuela 20101
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6490060
• MDR Text Key: 72706466
• Report Number: 3009211636-2017-05077
• Device Sequence Number: 1
• Product Code: NYU
• Combination Product (y/n): N
• Reporter Country Code: CI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2019
• Device Model Number: 8888145043P
• Device Catalogue Number: 8888145043P
• Device Lot Number: 1615300164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2017
• Initial Date FDA Received: 04/13/2017
• Supplement Dates Manufacturer Received: Not provided; 06/07/2017
• Supplement Dates FDA Received: 06/07/2017; 09/07/2017
• Date Device Manufactured: 06/03/2016
• 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