MAUDE Adverse Event Report: COVIDIEN LLC MAHURKAR; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	8813817009
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2024
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, during the insertion of the catheter, the introducer needle was already punctured, and a guidewire was inserted into the patient.When trying to insert the guidewire through the catheter, at that time, the guidewire did not pass through the catheter, and there was some blockage inside it.Flushing of the catheter was done when the guidewire did not pass through the catheter, and it was found that there was some blockage that suppressed the flow.Nothing unusual was observed in the product prior to use.They did not use other device with the catheter kit.There was no other damage present on the catheter or any other component.The catheter was not repaired.There was no leak.No cleaning agent was used on the device.No tego was utilized.Luer adapters were not used.The insertion site was treated with betadine prior to product placement.The doctor took back the catheter and used another acute dual lumen catheter kit on the same day with the same product id (identifier) and the same lot, which was from the co mpany they had kept in their inventory, and the procedure was completed.The procedure done only was the exchange of another catheter.No intervention or treatment was required for the event.There was no blood loss.A blood transfusion was not required at all.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: 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, during the insertion of the catheter, the introducer needle was already punctured, and a guidewire was inserted into the patient.When trying to insert the guidewire through the catheter, at that time, the guidewire did not pass through the catheter, and there was some blockage inside it that suppressed the flow.It was observed that the catheter tubing part was occluded as guidewire not passing from there.Flushing of the catheter was done, and they found that the result was not normal because somewhere the flow from the catheter was suppressed.Nothing unusual was observed in the product prior to use.They did not use other device with the catheter kit.There was no other damage present on the catheter or any other component.The catheter was not repaired.There was no leak.No cleaning agent was used on the device.No tego was utilized.Luer adapters were not used.The insertion site was treated with betadine prior to product placement.Customer did not reverse the lines.The occlusion was not due to thrombo sis.The guidewire used was the one from the kit.The doctor took back the catheter and used immediately another acute dual lumen catheter kit in their inventory on the same day with the same product id (identifier) and the same lot, which was from the company they had kept in their inventory, and the procedure was completed.The procedure done only was the exchange of another catheter.No intervention or treatment was required for the event.There was no blood loss.A blood transfusion was not required at all.There was no reported patient injury.
Event or Problem Description
According to the reporter, during the insertion of the catheter, the introducer needle was already punctured, and a guidewire was inserted into the patient.When trying to insert the guidewire through the catheter, at that time, the guidewire did not pass through the catheter, and there was some blockage inside it that suppressed the flow.It was observed that the catheter tubing part was occluded as guidewire not passing from there.Flushing of the catheter was done.Nothing unusual was observed in the product prior to use.They did not use other device with the catheter kit.There was no other damage present on the catheter or any other component.The catheter was not repaired.There was no leak.No cleaning agent was used on the device.No tego was utilized.Luer adapters were not used.The insertion site was treated with betadine prior to product placement.Customer did not reverse the lines.The occlusion was not due to thrombosis.The guidewire used was the one from the kit.The doctor took back the catheter and used immediately ano ther acute dual lumen catheter kit in their inventory on the same day with the same product id (identifier) and the same lot, which was from the company they had kept in their inventory, and the procedure was completed.The procedure done only was the exchange of another catheter.No intervention or treatment was required for the event.There was no blood loss.A blood transfusion was not required at all.There was no reported patient injury.
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted one mahurkar catheter.The returned catheter showed no visual abnormalities, however, when the guidewire was inserted into the catheter, it met an obstruction in the tip of the cannula.The cannula tip was cut open and an obstruction was observed.It was reported that the device was occluded.The reported issue was confirmed.The most likely cause was determined to be manufacturing related.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.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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: 19182314
• Report Number: 1282497-2024-00066
• Device Sequence Number: 7281008
• Product Code: FOZ
• UDI-Device Identifier: 10884521004917
• UDI-Public: 10884521004917
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/03/2025

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: 8813817009
• Device Catalogue Number: 8813817009
• Device Lot Number: 2315600127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 05/02/2024; 05/21/2024; 12/23/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/24/2024; 06/17/2024; 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2023
• 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 Sex: Unknown