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

Model Number	8888145041P
Medical Device Problem Codes	Product Quality Problem (1506); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted that the image depicts the guide wire and introduce needle.The j hook of the guide wire is located at the distal end of the introduce needle.The guide wires protective sheath and introducer needles sheath are in view.It was reported that the guide wire was unable to be withdrawn and there was a needle issue.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when puncturing the left jugular vein during catheter installation, the guide wire was guided by a needle but it entered with some resistance in the endoluminal tract.Given the resistance, the guide wire was decided to remove, but it did not come out, so the needle and guide wire had to be removed.The catheter was not repaired.There was no leak, no tego utilized and no luer adapter issue.There was no medical or surgical intervention needed to prevent a permanent impairment of a function.The event did not lead to or extend patient hospitalization.There was no patient symptoms or complications associated with the event.There was no patient injury.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the catheter appeared intact, and the guide wire was stuck inside the introducer needle.Functionally, the distal end of the cannula was clamped and a water bath test was performed on both sides.No air bubbles were detected.It was reported that the guide wire was unable to be withdrawn, and there was a needle issue.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: use the guidewire thumb advancer and straightener to insert the ""j"" end of the guidewire in to the introducer needle.Do not insert or withdraw the guidewire forcibly from any component; the wirer could break or unravel.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 10904670
• Report Number: 3009211636-2020-00289
• Device Sequence Number: 2713666
• Product Code: MSD
• UDI-Device Identifier: 10884521158047
• UDI-Public: 10884521158047
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 12/31/2024
• Device Model Number: 8888145041P
• Device Catalogue Number: 8888145041P
• Device Lot Number: 2002100138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1