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

Model Number 8888145057P

Device Problem Material Fragmentation (1261)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 06/05/2023

Event Type  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.

Event Description

According to the reporter, one of the vascular surgeons implanted a precision his (heparin coated & silver ion antimicrobial) chronic catheter kit on the day of the event.The thumb handle piece (which was used when peeling away the sheet) broke off and completely separated when it was attempted to be peeled away.There was nothing unusual observed on the device prior to use.Aside from the reported issue, there were no other visible defects/damages found on the product.Flushing was done prior to use with no problem.There was no leak.There were no other products being utilized with the device.There were no resistance when the pull apart sheath was being inserted.There was no excessive force applied on the device.The catheter was already in place when the sheath broke apart.The sheath piece fell into the patient's body.A hemostat was used to grab the end of the sheath to retrieve the piece from the patient, and an x-ray machine was used to make sure all the pieces of the sheath were retrieved.All the pieces were retrieved from the patient.This created a challenge for the surgeon, but the peel-away process was successfully completed.This was a patient-safety issue and lack of quality.The surgeon was able to complete the insertion process without a new product.The procedure was completed.There was no blood loss and blood transfusion was not required.There were no other intervention/treatment aside from retrieving the sheath piece from the patient's body.

Event Description

According to the reporter, one of the vascular surgeons implanted a precision his (heparin coated <(>&<)> silver ion antimicrobial) chronic catheter kit on the day of the event.The thumb handle piece (a hub which was used when peeling away the sheet) broke off from the sheath and completely separated when it was attempted to be peeled away.The sheath that was used was included in the kit.There was nothing unusual observed on the device prior to use.Flushing was done prior to use with no problem.Aside from the reported issue, there were no other visible defects/damages found on the product.There was no leak and no dimension issue noted on the sheath.There were no other products being utilized with the device.There were no resistance when the pull apart sheath was being inserted.There was no excessive force applied on the device.The catheter was already in place when the hub broke apart from the sheath but it did not fell into the patient's body.As a remedial action, a hemostat was used to grab the end of the peel-away sheath, and an x-ray machine was used to make sure all the pieces of the sheath were retrieved.All the pieces were retrieved from the patient.This created a challenge for the surgeon, but the peel-away process was successfully completed.This was a patient-safety issue and lack of quality.The surgeon was able to complete the insertion process without a new product.The procedure was completed.There was no blood loss and blood transfusion was not required.There were no other intervention/treatment aside from retrieving the peel-away sheath piece.

Manufacturer Narrative

Additional information: b5, g3 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

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 one of the tabs of the pull apart sheath had detached from the sheath.The sheath itself also appeared ragged and deformed at the end in a way that was inconsistent with the normal operation of the device.It was reported that the sheath fragmented.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 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, one of the vascular surgeons implanted a precision his (heparin coated <(>&<)> silver ion antimicrobial) chronic catheter kit on the day of the event.The thumb handle piece (a hub that was used when peeling away the sheet) broke off from the sheath and completely separated when it was attempted to be peeled away.The sheath that was used was included in the kit.There was nothing unusual observed on the device prior to use.Flushing was done prior to use with no problem.Aside from the reported issue, there were no other visible defects/damages found on the product.There was no leak and no dimension issue noted on the sheath.There were no other products being utilized with the device.There was no resistance when the pull apart sheath was being inserted.There was no excessive force applied to the device.The catheter was already in place when the hub broke apart from the sheath, but it did not fell into the patient's body.As a remedial action, a hemostat was used to grab the end of the peel-away sheath, and an x-ray machine was used to make sure all the pieces of the sheath were retrieved.All the pieces were retrieved from the patient.This created a challenge for the surgeon, but the peel-away process was successfully completed.This was a patient-safety issue and a lack of quality.The surgeon was able to complete the insertion procedure without a new product.There was no blood loss, and blood transfusion was not required.There was no other intervention/treatment aside from retrieving the peel-away sheath piece.

• 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: 17176440
• MDR Text Key: 317631258
• Report Number: 3009211636-2023-00175
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521158276
• UDI-Public: 10884521158276
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145057P
• Device Catalogue Number: 8888145057P
• Device Lot Number: 2204000085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 06/05/2023; 08/16/2023
• Supplement Dates FDA Received: 07/13/2023; 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2022
• 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 Outcome(s): Required Intervention