MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED, COATED

Model Number	8888145046P
Medical Device Problem Codes	Break (1069); Product Quality Problem (1506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during procedure, the stylet broke off in the catheter¿s lumen at the proximal part.The catheter was removed and replaced by another catheter.The patient¿s new catheter worked, but during the second insertion of the stylet, the physician stated that it was also difficult to remove, the material of the stylet was stretched and almost broke off as well.The piece that broke off in the lumen within the catheter was removed from the patient and nothing was left behind.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: a device history 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.All dhr (device history review) are reviewed for accuracy prior to product release.One sample was provided.Visual evaluation of this sample was performed; and it was observed one stylet broken and showed signs of being manipulated.As part of the testing we tried to replicate according use of the labeling instruction.According to testing, if the guidewire was not removed first and it was tried to remove first, the stylet that was placed in the arterial lumen could exert a force that causes it to break that was similar to the reported defect.The product sample was returned for evaluation.The reported condition has been confirmed.A manufacturing defect could not be related to the reported condition.The most probable cause was identified as man/customer misuse inadequate manipulation of the components.No trends or triggers have been found.No action is deemed necessary at this time.It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED, COATED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7371430
• Report Number: 3009211636-2018-00091
• Device Sequence Number: 18844274
• Product Code: NYU
• UDI-Device Identifier: 20884521158136
• UDI-Public: 20884521158136
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2018
• Device Model Number: 8888145046P
• Device Catalogue Number: 8888145046P
• Device Lot Number: 1526000209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR