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

Model Number 8888145044CP

Device Problems Product Quality Problem (1506); Difficult to Remove (1528); Unraveled Material (1664); Insufficient Flow or Under Infusion (2182)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 01/25/2023

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

According to the reporter, there was placement of a catheter in the ¿right internal jugular d¿ without foreseeable difficulty in a patient who had previously received ¿vvc¿ in the past and already benefited from a central venous line without visible stenosis.When the vein was punctured, there was a failure to descend the guidewire, probably due to the needle coming out of the vein.The guidewire of the reported 23 centimeters (cm) catheter kit was damaged/deteriorated following this step because it got stuck in the bevel of the needle and was damaged when released.Therefore, a competitor hydrophilic radifocus guide wire m with a length of 180 centimeter (cm) and a diameter of 0.89 millimeters (mm) was used.The puncture was carried out without difficulty and the guide was lowered.At this stage of the installation, fluoroscopy (radioscopy) was not used in the absence of foreseeable difficulty.The catheter was then tunneled retrograde, the jugular site was prepared for dilation of the vein and then the descent of the dilators begun.The first dilator of small caliber descended without difficulty or pain.When the second dilator was placed, a resistance was reported.After inspection, it was observed that the end of the dilator was slightly twisted/bent as a result of the previous difficulty, which can happen sometimes.However, the dilator was still considered usable, and the second dilator and the third dilator were lowered with a slight but not excessive resistance at first.On the other hand, the patient was algesic and had pain when the dilators were lowered.The pain was not exceptional and therefore the procedure was continued until the introduction of the catheter which was slightly sensitive.On testing after descent of the catheter, it was noted that there was an absence of return without visible bend and without a visible elbow.Therefore, an x-ray/radioscope was asked and an abnormal position of the catheter in the left part of the upper mediastinum was noticed.So, the procedure was interrupted.The catheter was fixed, and a computerized tomography (ct) was requested to check the position.The non-injected ct scan due to lack of venous capital confirmed the extravascular and intra-mediasti nal position of the catheter.There was no leak and no luer adapter issue.The insertion site was treated prior to product placement.The catheter was explanted.

Manufacturer Narrative

Additional information: g3 correction: h6 (coding changes: added needle issue as secondary) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

According to the reporter, there was placement of a catheter in the ¿right internal jugular d (right)¿ without foreseeable difficulty in a patient who had previously received ¿vvc¿ in the past and already benefited from a central venous line without visible stenosis.When the vein was punctured, there was a failure to descend the guidewire, probably due to the needle coming out of the vein.The guidewire of the reported 23 centimeters (cm) catheter kit was damaged/deteriorated following this step because it got stuck in the bevel of the needle and was damaged when released.Therefore, a competitor hydrophilic radifocus guide wire m with a length of 180 centimeter (cm) and a diameter of 0.89 millimeters (mm) was used.The puncture was carried out without difficulty and the guide was lowered.At this stage of the installation, fluoroscopy (radioscopy) was not used in the absence of foreseeable difficulty.The catheter was then tunneled retrograde, the jugular site was prepared for dilation of the vein and then the descent of the dilators begun.The first dilator of small caliber descended without difficulty or pain.When the second dilator was placed, a resistance was reported.After inspection, it was observed that the end of the dilator was slightly twisted/bent as a result of the previous difficulty, which can happen sometimes.However, the dilator was still considered usable, and the second dilator and the third dilator were lowered with a slight but not excessive resistance at first.All the three dilators used were all included on the reported product.On the other hand, the patient was algesic and had pain when the dilators were lowered.The pain was not exceptional and therefore the procedure was continued until the introduction of the catheter which was slightly sensitive.On testing after descent of the catheter, it was noted that there was an absence of return without visible bend and without a visible elbow.Therefore, an x-ray/radioscope was asked and an abnormal position of the catheter in the left part of the upper mediastinum was noticed.So, the procedure was interrupted.The catheter was fixed, and a computerized tomography (ct) was requested to check the position.The non-injected ct scan due to lack of venous capital confirmed the extravascular and intra-mediastinal position of the catheter.There was no leak and no luer adapter issue.The insertion site was treated prior to product placement.The catheter was explanted.The guidewire was removed by hand in one action.The guidewire was still intact when it was removed.As a remedial action, the catheter was removed and a new one was inserted a few days later with the same product id and lot.The procedure was completed after the remedial action was done.There was no blood transfusion required.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED, COATED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18712907
• MDR Text Key: 335482303
• Report Number: 3009211636-2024-00061
• Device Sequence Number: 1
• Product Code: NYU
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145044CP
• Device Catalogue Number: 8888145044CP
• Device Lot Number: 2320800111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 02/23/2024; 04/09/2024
• Supplement Dates FDA Received: 03/19/2024; 04/26/2024
• Date Device Manufactured: 09/11/2023
• 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
• Patient Age: 72 YR
• Patient Sex: Female