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

Model Number 8888135132

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Integrity Problem (2978)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 10/13/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, at 14:00 on (b)(6) 2021, the patient came to the hospital for dialysis due to uremia.The central venous catheter kit for hemodialysis was placed under the guidance of color doppler ultrasound.During this period, the professional performed normal operations and the position for catheter placement was successfully located under the guidance of color doppler ultrasound.Resistance was felt during retention with the guide wire.After it was retreated and entered again, the resistance was felt to be disappeared.The color doppler ultrasound confirmed that the catheter on the dialysis machine was not able to draw blood smoothly and the venous blood did not return.The chest radiograph inspection was performed immediately for the patient.The report showed that the tip of the catheter was turned/folded back, resulting in inability to draw blood smoothly and perform dialysis.It was communicated with the patient to make an appointment with color doppler ultrasound to adjust the position on a future date, if the adjustment failed, a new central venous catheter kit for hemodialysis will be used in another position.Nothing unusual observed prior to procedure.The catheter was not repaired and had no leak.Tego was not utilized.There was no luer adapter issue.The insertion site was not treated prior to product placement.No other products being utilized with the device.The lumens were flushed prior to use.There was a blood return prior to syringe flush but reverse flow was not successful.There was no blood loss and no blood transfusion was required.No medical intervention/treatment was provided due to the event.It was said that on (b)(6), the patient had the said catheter adjustment under the guidance of b-ultrasound, after the guide wire was fed in, the catheter was then withdrawn.The tip of the catheter was said to had obvious folding marks which could not be restored.Worrying that it might break, the surgeon discarded the catheter, and chose to re-insert the tube in the right femoral vein.It was said that the final patient outcome was stable, no special discomfort except of the inability to normal dialysis.

Manufacturer Narrative

Correction: a5a, a5b, e1(first name, last name), g3, h6 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

Additional information: b5, g3, h3, h6 correction: g1(mfr contact first name, last name, email and phone number) h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but photos were available for evaluation.Visual inspection noted two x-rays but it was unclear to see the catheter.It was reported that there was an insufficient flow issue, the catheter was kinked and the device was occluded.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 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, at 14:00 on (b)(6) 2021, the patient came to the hospital for dialysis due to uremia.The central venous catheter kit for hemodialysis was placed under the guidance of color doppler ultrasound.During this period, the professional performed normal operations and the position for catheter placement was successfully located under the guidance of color doppler ultrasound.Resistance was felt during retention with the guide wire.After it was retreated and entered again, the resistance was felt to be disappeared.The color doppler ultrasound confirmed that the catheter on the dialysis machine was not able to draw blood smoothly and the venous blood did not return.The chest radiograph inspection was performed immediately for the patient.The report showed that the tip of the catheter was turned/folded back, resulting in inability to draw blood smoothly and perform dialysis.It was communicated with the patient to make an appointment with color doppler ultrasound to adjust the position on a future date, if the adjustment failed, a new central venous catheter kit for hemodialysis will be used in another position.Nothing unusual observed prior to procedure.The catheter was not repaired and had no leak.Tego was not utilized.There was no luer adapter issue.The insertion site was not treated prior to product placement.No other products being utilized with the device.The lumens were flushed prior to use.It was said that when the line was flushed with syringe, the arterial end was noted to be unobstructed, but the venous end was obstructed.There was a blood return prior to syringe flush but reverse flow was not successful.There was no blood loss and no blood transfusion was required.No medical intervention/treatment was provided due to the event.It was said that on oct 15, the patient had the said catheter adjustment under the guidance of b-ultrasound, after the guide wire was fed in, the catheter was then withdrawn.The tip of the catheter was said to had obvious folding marks which could not be restored.Worrying that it might break, the surgeon discarded the catheter, and chose to re-insert the tube in the right femoral vein.It was said that the final patient outcome was stable, no special discomfort except of the inability to normal dialysis.

• Brand Name: MAHURKAR
• Type of Device: CATHETER, HEMODIALYSIS, NON-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: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 12769330
• MDR Text Key: 280445098
• Report Number: 3009211636-2021-00312
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006218
• UDI-Public: 10884521006218
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888135132
• Device Catalogue Number: 8888135132
• Device Lot Number: 2007800043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2020
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 49 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian