MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPL

Model Number	8888101002HP
Medical Device Problem Codes	Material Fragmentation (1261); Unraveled Material (1664)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Unintended Radiation Exposure (4565)
Date of Event	10/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, the critical care was placing a dialysis catheter into the patient, and a piece of the guide wire broke off in the patient when the guidewire was being pulled out.The guidewire broke at the distal end.The patient had to be transferred for ct (cardiothoracic) surgery to have it removed.It was stated that on removal of the guidewire (when the guidewire broke off onthe day of the event), it was immediately recognized that the guidewire's braided end was unraveled at distal tip with 1 of three braid fragments foreshortened.The cxr (chest x-ray) confirmed radiopaque curve linear opacity in the r (right) neck which was suggestive of retained guidewire fragment.The patient was sent for ct (computerized tomography) chest without contrast, which confirmed retained guidewire fragment in the r (right) paratracheal area.It was stated that it was reviewed immediately with a vascular surgery, ¿ir¿ (interventional radiology), and ¿ctsx¿ (cardiothoracic surgery).Per ¿ir¿ (interventional radiology) review, they did not believe the fragment to be currently endovascular and did not feel ¿ir (interventional radiology) approach¿ for retrieval was possible.This was discussed with a doctor who felt that this will be approachable by r (right) sided neck exploration for retrieval.It was stated that on 11/03, a right sided neck exploration was done by a vascular surg.(surgeon).The retained guidewire was removed and retrieved intact under fluoroscopy vein repaired at the hospital.There was no excessive force required to remove the guidewire, and there was no excessive force used on the device.The guidewire provided with the kit was being used.There was nothing unusual observed on the device prior to use.There was no resistance when inserting the guidewire.Prior to breaking, there were no abnormal conditions.Besides the reported issue, there were no other reported visible defects/damages found on the product at the time of the event.There was no other product utilized with the device/central line acute triple lumen catheter.Since the patient was transferred to a hospital for vascular surgery, they were not able to proceed and complete the procedure.The current and pre-existing patient conditions of the patient that may be related to the event were acute kidney injury, pancreatic ascites, pancreatic pseudo cyst, acute respiratory failure, lupus, encephalopathy, and pancreatitis.Besides what was stated above, there was no other medical intervention/treatment done to the patient in relation to the guidewire.There was no blood loss documented.The patient status right after the event was stable.
Additional 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.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPL
• 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: 18468193
• Report Number: 3009211636-2024-00014
• Device Sequence Number: 3088191
• Product Code: NIE
• UDI-Device Identifier: 10884521127968
• UDI-Public: 10884521127968
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K102605
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/08/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2025
• Device Model Number: 8888101002HP
• Device Catalogue Number: 8888101002HP
• Device Lot Number: 2307900094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2024
• Date Device Manufactured: 06/13/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Race: White