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

Model Number 8888145014

Device Problems Insufficient Flow or Under Infusion (2182); Material Deformation (2976); Insufficient Information (3190)

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

Event Date 05/20/2022

Event Type  malfunction  

Event Description

According to the reporter, the catheter was implanted on the (b)(6) and x-ray was done on initial device placement wherein bent at normal arc was noted.During dialysis on the (b)(6), creases were visible in the natural arc of the vessel through x-ray.It was said that before undergoing the x-ray process, normal angle kink, insufficient flow was noted and there was a decreased dialysis quality.And after the catheter was removed, there were obvious depressions in the catheter.There was no leak.Tego was not utilized.There was no luer adapter issue.No cleaning agent was used on the device.No other products were being utilized with the device.The catheter was not repaired.There was no blood loss and no blood transfusion was required.No other medical intervention/treatment was done due to the event.It was said that after the catheter was removed, a new catheter was needed to be re-implanted through a secondary operation then the patient returned to a normal dialysis and it was completed.There was no reported patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: b5, g3, h6 new information has been received, and reassessment of the complaint found that it is no longer a reportable issue.The event is no longer associated with a serious injury or potential for serious injury with reoccurrence.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, the catheter was implanted on the (b)(6) may, and during that day, there were no issues noted and there was no imaging done.During dialysis on the (b)(6) may, creases (bent) were visible in the natural/normal arc of the vessel through x-ray.It was said that before undergoing the x-ray process, normal angle kink, insufficient flow was noted and there was a decreased in the dialysis quality.And after the catheter was removed, there were obvious depressions in the catheter.It was said that all the issues were noted on the (b)(6)may.There was no leak.Tego was not utilized.There was no luer adapter issue.No cleaning agent was used on the device.No other products were being utilized with the device.The catheter was not repaired.There was no blood loss and no blood transfusion was required.No other medical intervention/treatment was done due to the event.It was said that after the catheter was removed, a new catheter was needed to be re-implanted (same day) through a secondary operation then the patient returned to a normal dialysis and it was completed.There was no reported patient injury.

• 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: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 14836401
• MDR Text Key: 302701074
• Report Number: 3009211636-2022-00160
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521013148
• UDI-Public: 10884521013148
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• 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: 2116500155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2022
• 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: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian