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

Model Number	8888135191
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/18/2024
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.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, on the day of the event, the designated department of the facility reported that during the femoral vein puncture for the patient, the doctor used a central venous catheter kit for hemodialysis, and the guidewire in the central venous catheter broke, resulted in the puncture failure.The catheter was re-pierced/re-punctured.Due to the event, the critically ill patient was repeatedly punctured.The anticipated treatment due to the event was blood purification.There was no reported patient outcome.
Additional Manufacturer Narrative
Additional information: a4, b5, g3, h6.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, on the day of the event, the designated department of the facility reported that during the femoral vein puncture for the patient, the central venous catheter kit for hemodialysis was used by the doctor.It was stated that the guidewire in the central venous catheter broke, which resulted in puncture failure.There was no leak.There was no luer adapter issue.There was nothing unusual observed on the device prior to use.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.Flushing was not done prior to use.Tego was not utilized.There was no cleaning agent used on the device.There were no other products being utilized with the device.There was no excessive force used on the device.The guidewire was removed by hand.It was necessary to remove the guide wire and catheter from the patient simultaneously (in one action) due to the alleged defect.The guidewire was still intact when removed, and all the pieces were accounted for.As a remedial action, the reported product, including the guidewire, was replaced.The procedure was then continued, re-puncture was done, and the catheter was placed.The procedure was completed after the remedial action was done.The anticipated treatment due to the event was blood purification.It was stated that due to the event, the critically ill patient was repeatedly punctured.There was no blood loss, and a blood transfusion was not required due to the event.The patient was stable right after the event.There was no reported patient injury.

• Brand Name: MAHURKAR
• Common Device Name: 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: 20224097
• Report Number: 1282497-2024-00387
• Device Sequence Number: 12594562
• Product Code: MPB
• UDI-Device Identifier: 10884521006447
• UDI-Public: 10884521006447
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K192302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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: 8888135191
• Device Catalogue Number: 8888135191
• Device Lot Number: 2311000346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/02/2024
• Date Device Manufactured: 05/13/2023
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 60 KG