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

Model Number 8888135161

Device Problems Product Quality Problem (1506); Difficult to Remove (1528)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2024

Event Type  malfunction  

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 Description

According to the reporter, during procedure, the guide wire did not pass through the introducer needle, needle presented resistance.It was also noted that guide wire could not be removed from the needle.There was no reported patient outcome.

Manufacturer Narrative

Additional information: 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, during procedure, the guide wire did not pass through the introducer needle in one action, needle presented resistance.It was also noted that guide wire could not be removed from the needle.The guidewire used was the the one included in the catheter kit.There was no leak.There was nothing unusual observed on the device prior to use and there were no other defects/damages found on the guide wire.There was no excessive force used on insertion and withdrawal of the guide wire.The guidewire was still intact (not break into two or into pieces) when it was removed.The guidewire was removed manually and no tools used.There was no cleaning agent used on the device.The insertion site was treated with clorhexidina solution prior to product placement.There were no other products being utilized with the device.Flushing was not done prior to use.As a remedial action and to resolve the issue, the trocar was changed from other manufacturer to reinsert the guide.The procedure was completed after resolving the issue.There was no blood loss, and no blood transfusion was required.There was no intervention/medical treatment required as the result of the event.There was no reported patient outcome.

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 Description

According to the reporter, during procedure, the guide wire did not pass through the introducer needle in one action, needle presented resistance.It was also noted that guide wire could not be removed from the needle.The guidewire used was the one included in the catheter kit.There was no leak.There was nothing unusual observed on the device prior to use and there were no other defects/damages found on the guide wire.There was no excessive force used on insertion and withdrawal of the guide wire.The guidewire was still intact (not break into two or into pieces) when it was removed.The guidewire was removed manually and no tools used.There was no cleaning agent used on the device.The insertion site was treated with clorhexidina solution prior to product placement.There were no other products being utilized with the device.Flushing was not done prior to use.As a remedial action and to resolve the issue, double puncture performed, the material used to perform this new puncture was a trocar size 14, this material was from another supplier.The procedure was completed after resolving the issue.There was no blood loss, and no blood transfusion was required.There was no intervention/medical treatment required as the result of the event.There was no reported patient injury.

• Brand Name: MAHURKAR
• 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: 19116725
• MDR Text Key: 340572612
• Report Number: 1282497-2024-00044
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006355
• UDI-Public: 10884521006355
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K192302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2024

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: 8888135161
• Device Catalogue Number: 8888135161
• Device Lot Number: 2311000365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 04/11/2024; 04/29/2024
• Supplement Dates FDA Received: 05/02/2024; 05/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2023
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 79 KG