MAUDE Adverse Event Report: COVIDIEN LLC MAHURKAR ELITE; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number 8888221320

Device Problems Product Quality Problem (1506); Unraveled Material (1664)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 11/29/2023

Event Type  Injury  

Event Description

According to the reporter, during the procedure of inserting the reported catheter, the resident advanced the guidewire through the introducer needle to the 10cm (centimeter) mark and then had resistance to advance it further.The resident pulled back on the guidewire and the guidewire unraveled.There was no leak and no luer adapter issue.There was no packaging damage observed.Tego was not utilized.The insertion site was treated prior to product placement.The customer utilized the chloraprep swabs included in the tray to clean the insertion site.The customer had the wire and the packages.The catheter was not repaired.The patient received an x-ray to confirm that no particles were left in the patient.None were found and no patient injury was reported.As a remedial action a new dual lumen catheter was placed.The procedure was completed.

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.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

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 procedure of inserting the reported catheter, the resident advanced the guidewire through the introducer needle to the 10cm (centimeter) mark and then had resistance to advance it further.The resident pulled back on the guidewire and the guidewire unraveled.The guidewire was provided with the kit being used.There was no leak and no luer adapter issue.There was no packaging damage observed.There was nothing unusual observe on the device prior to use.Flushing was done prior to use with normal result.There was no cleaning agent used on the device as product was sterile from the packaging.Tego was not utilized.The insertion site was treated prior to product placement.The customer utilized the chloraprep swabs included in the tray to clean the insertion site.The customer has the wire and the packages.The catheter was not repaired.The patient received an xray to confirm that no particles were left in the patient.None were found and no patient injury was reported.As a remedial action a new dual lumen catheter was placed.The procedure was completed.Besides the x-ray no additional treatment was needed.

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.A comprehensive examination could not be performed, because the returned sample was not received in a state that allowed full functional or visual assessment.It was reported that the guide wire was frayed, coiled or unravelled, and there was a needle issue.The reported issues could not be 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MAHURKAR ELITE
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• 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: 18432154
• MDR Text Key: 331845336
• Report Number: 3009211636-2024-00002
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521126381
• UDI-Public: 10884521126381
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2024

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: 8888221320
• Device Catalogue Number: 8888221320
• Device Lot Number: 2306100127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 01/26/2024; 05/07/2024
• Supplement Dates FDA Received: 02/15/2024; 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2023
• 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 Outcome(s): Other; Required Intervention