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

Model Number	8888133505P
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Additional 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during a tunnel dialysis catheter exchange, the stylet broke off inside the catheter within the shaft.The catheter was not repaired.There was no leak.There was no luer adapter issue.The stylet used was the stylet included in the kit.No pieces of the stylet fell into the patient's body.Nothing unusual was observed on the device prior to use.No other defects or damage were found on the product.Flushing was  done prior to use.No other products were being utilized with the device.The product was placed in the ir (intervention radiology)/catheter laboratory.The catheter was removed with the stylet and replaced with another, same-brand with the same lot and product id (identifier) catheter.No intervention or treatment was required as a result of the event.No x-ray machine was used or performed.There was no blood loss.A blood transfusion was not required.There was no reported patient injury.
Additional 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.
Event or Problem Description
According to the reporter, during a tunnel dialysis catheter exchange, the stylet broke off inside the catheter within the shaft.The catheter was not repaired.There was no leak.There was no luer adapter issue.The stylet used was the stylet included in the kit.No pieces of the stylet fell into the patient's body.Nothing unusual was observed on the device prior to use.No other defects or damage were found on the product.Flushing was done prior to use and it was normal.No other products were being utilized with the device.The product was placed in the ir (intervention radiology)/catheter laboratory.The catheter was removed with the stylet and replaced with another, same-brand with the same lot and product id (identifier) catheter.No intervention or treatment was required as a result of the event.No x-ray machine was used or performed.There was no blood loss.A blood transfusion was not required.There was no reported patient injury.
Event or Problem Description
According to the reporter, during a tunnel dialysis catheter exchange, the 52 cm (centimeter) stylet broke off inside the catheter within the shaft.The catheter was not repaired.There was no leak.There was no luer adapter issue.The stylet used was the stylet included in the kit.No pieces of the stylet fell into the patient's body.Nothing unusual was observed on the device prior to use.No other defects or damage were found on the product.Flushing was done prior to use and it was normal.No other products were being utilized with the device.The product was placed in the ir (intervention radiology)/catheter laboratory.The catheter was removed with the stylet and replaced with another, same-brand with the same lot and product id (identifier) catheter.No intervention or treatment was required as a result of the event.No x-ray machine was used or performed.There was no blood loss.A blood transfusion was not required.There was no reported patient injury.
Additional 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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted one palindrome catheter along with one stylet which was returned in two pieces.One piece (proximal end) was returned separately and the other segment was stuck in the arterial extension tube and was inaccessible.The arterial luer adapter was cut off so the stylet could be accessed.The stylet was removed without too much force and a large amount of dried blood was also removed.Both ends of the stylet where the break occurred showed evidence of necking.This suggests that the stylet was stuck and the customer exerted a lot of force to try and remove it.The inside of the cannula was examined but no obstructions were found besides dried blood.It was reported that the stylet broke apart.The reported issue was 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 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
• Common Device Name: 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: 19249749
• Report Number: 1282497-2024-00085
• Device Sequence Number: 7309917
• Product Code: NYU
• UDI-Device Identifier: 10884521157927
• UDI-Public: 10884521157927
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/15/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8888133505P
• Device Catalogue Number: 8888133505P
• Device Lot Number: 2332700275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 05/02/2024; 05/13/2024; 07/11/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/24/2024; 06/04/2024; 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female