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

Model Number 8888145014P

Device Problem Material Fragmentation (1261)

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

Event Date 08/07/2023

Event Type  malfunction  

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, during the removal of the peel-away sheath, it did not come out of the patient completely.A very small strip was detached from the peel-away sheath and did not remain in the patient.There was no leak and there was no luer adapter issue.The catheter was not repaired and tego was utilized.There was no cleaning agent used on the device and the insertion site was treated with chlorhexidine prior to product placement.It was stated that there was a possibility that the product will be returned but it was still in the possession of facility.There was nothing unusual observed on the device prior to use, no other damages found on the peel-away sheath and there were no other products utilized with the device.Flushing was done with normal result.The peel-away sheath used was the one included in the catheter kit.No excessive force was applied when removing the sheath.The small strip was immediately retrieved from the patient's body after it fell and it came when it was pulled out manually.X-ray machine was not used to check for the retained pieces and there were no procedures performed.Procedure was completed.The event did not result to patient having vessel damage.The patient had no current and pre-existing conditions that may be related to the event.There was no blood loss and blood transfusion was not required.There was no medical intervention as a result of the event.The patient was in stable condition and had no further issues.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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 17647633
• MDR Text Key: 322288947
• Report Number: 3009211636-2023-00242
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521157972
• UDI-Public: 10884521157972
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Physician
• Type of Report: Initial
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145014P
• Device Catalogue Number: 8888145014P
• Device Lot Number: 2234800155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2023
• Date Device Manufactured: 01/28/2023
• 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 Age: 81 YR
• Patient Sex: Male
• Patient Weight: 93 KG