MAUDE Adverse Event Report: COVIDIEN LLC PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED, COATED

Model Number 8888145044CP

Device Problem Break (1069)

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

Event Date 01/24/2024

Event Type  malfunction  

Event Description

According to the reporter, the 23 centimeter catheter was implanted into the patient and during the removal of the catheter, the catheter was torn (broke) at the attachment piece and had to be removed on the same day of the event and replaced with another model.The catheter was not repaired.The patient had no further complications and there was no reported patient 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.

Manufacturer Narrative

Additional information: a2, b5, g3 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, the 23 centimeter catheter was implanted into the patient and during the removal of the catheter, the catheter shaft was torn (broke) at the attachment piece and had to be removed on the same day of the event and replaced with another model to resolve the issue.The catheter was not repaired.There was nothing unusual observed on the device prior to use.No other products utilized with the device.Flushing was not performed.Sepsiderm was not used to clean catheter and there was no change in protocol for the cleaning agents used recently.There were no current and pre-existing conditions of the patient that may be related to the event.The patient had no further complications and there was no reported patient injury.

Manufacturer Narrative

Additional information: b5, d3 (mfr name, street 1, mfr city, mfr region, country code, postal code), e1(prefix, first name, last name), e2, e3, g3 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, the 23 centimeter catheter was implanted into the patient and during the removal of the catheter, the catheter shaft was torn (broke) at the attachment piece (screw connection) and had to be removed on the same day of the event and replaced with a competitor's product on the same day to resolve the issue.The catheter was not repaired.There was nothing unusual observed on the device prior to use.No other products utilized with the device.Flushing was not performed.Sepsiderm was not used to clean catheter and there was no change in protocol for the cleaning agents used recently.There were no current and pre-existing conditions of the patient that may be related to the event.The patient had no further complications and there was no reported patient injury.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED, COATED
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18777207
• MDR Text Key: 337295013
• Report Number: 3009211636-2024-00066
• Device Sequence Number: 1
• Product Code: NYU
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K123196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145044CP
• Device Catalogue Number: 8888145044CP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 03/04/2024; 04/02/2024
• Supplement Dates FDA Received: 03/29/2024; 04/26/2024
• 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: 67 YR
• Patient Sex: Female