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

Model Number 8888145014

Device Problems Material Frayed (1262); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during procedure, the guidewire was stuck in the whole needle and could not be pulled out (the guidewire was also unraveled on the provided picture).There was resistance in removing the needle.The guidewire that was stuck was removed by hand and was broken in the distal end when it was removed.It was stated that the guidewire was removed together with the introducer needle.Flushing was done prior to use.A new product was opened to resolve the issue.There was an unspecified amount of blood loss, but no blood transfusion was required.The guidewire used was the one provided with the kit being and all pieces were accounted for.There were no other products being utilized with the device.The catheter was not repaired.There was no leak and no tego was utilized.There was no luer adapter issue.There were no visible defects/damages found on the product.There was no packaging damage.There were no patient symptoms or complications associated with the event.There was no patient injury.

Event Description

According to the reporter, during procedure, the guidewire was stuck in the whole needle and could not be pulled out (the guidewire was also unraveled on the provided picture).There was resistance in removing the needle.The guidewire that got stuck was removed by hand and was broken in the distal end when it was removed out of the patient.It was stated that the guidewire was removed together with the introducer needle.Flushing was done prior to use.A new product was opened to resolve the issue.There was an unspecified amount of blood loss, but no blood transfusion was required.The guidewire used was the one provided with the kit being and all pieces were accounted for.There were no other products being utilized with the device.The catheter was not repaired.There was no leak and no tego was utilized.There was no lue adapter issue.There were no visible defects/damages found on the product observed.There was no packaging damage.There were no patient symptoms or complications associated with the event.There was no patient injury.

Manufacturer Narrative

Additional information: b5, g1 (manufacturer name, mfr contact first name, last name, street 1, mfr city, email, phone number).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.

Manufacturer Narrative

H3 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 guidewire was deformed and appeared to be stuck in the introducer needle.It was reported that the guide wire was unable to be withdrawn and unravelled.The reported issues were 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.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.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.

Manufacturer Narrative

Medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the catheter was received, and it was noted the guide wire was extremely frayed.The introducer needle had dried blood but appeared intact.Functionally, a test guide wire was used to insert into the puncture needle to check for occlusion.It was inserted and removed cleanly many times.The catheter was submerged into a water bath and the ends were clamped, and a syringe was used to inject air to observe leakage.No air bubbles were present and both extensions were tested with acceptable results.The test guide wire was inserted into the lumen and passed through without occlusion.It was reported that the guide wire was unable to be withdrawn and the guide wire was unraveled.The reported issues were 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.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
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• 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: avi kluger ; 5920 longbow drive; boulder,co, MA 80301 ; 3035306582
• MDR Report Key: 11731431
• MDR Text Key: 247702305
• Report Number: 3009211636-2021-00091
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521013148
• UDI-Public: 10884521013148
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K111372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145014
• Device Catalogue Number: 8888145014
• Device Lot Number: 2023300124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2020
• 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 Age: 79 YR
• Patient Sex: Female