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

Model Number	8888101002HP
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Death (1802)
Date of Event	04/04/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, patient was on an emergent case and came in with chest pain and needed stent placement, during the placement of triple lumen dialysis catheter, the patient was placed in the supine position in mild trendelenberg.Under ultrasound guidance, the left femoral vein was identified.The patient was then draped and prepped in the usual sterile manner.After adequate local anesthesia was obtained, the vein was cannulated.Using seldinger technique, a guide wire was advanced without resistance.Imaging of the guidewire confirm that guidewire outside vein.Guidewire was removed and was found to be kinked and all became unraveled with fixed resistance at one point.Available dilator was applied, and the guidewire retracted but was unsuccessful.Smaller dilator was used and with retraction, successfully removed (complete).Pressure was applied to area until hemostasis.At the second attempt, using seldinger technique, a guide wire was advanced without resistance.After the subcutaneous skin was appropriately dilated, a fr (french) 20 cm triple lumen dialysis catheter was placed.Both dialysis ports and third access port were easily aspirated and flushed with normal saline and the catheter sutured to the skin using 2-0 silk.The catheter was in place for five (5) days before the patient expired.It was later reported that the patient was deceased, and cardiogenic shock was determined to be the cause of death.It is unknown at this time if the device caused or contributed to the event.
Event or Problem Description
According to the reporter, patient was on an emergent case and came in with chest pain and needed stent placement.During the placement of triple lumen dialysis catheter, the patient was placed in the supine position in mild trendelenberg.Under ultrasound guidance, the left femoral vein was identified.The patient was then draped and prepped in the usual sterile manner.After adequate local anesthesia was obtained, the vein was cannulated.Using seldinger technique, a guide wire was advanced without resistance.Imaging of the guidewire confirm that it was outside the vein.Guidewire was removed and was found to be kinked and all became unraveled with fixed resistance at one point.Available dilator was applied, and the guidewire retracted but was unsuccessful.Smaller dilator was used and with retraction, successfully removed (complete).Pressure was applied to area until hemostasis.At the second attempt, using seldinger technique, it was advanced without resistance.After the subcutaneous skin was appropriately dilated, a fr (french) 20 cm triple lumen dialysis catheter was placed.Flushing was done, a cleaning agent was not used on the device, the insertion site was treated with chlorhexidine and lidocaine prior to product placement.Both dialysis ports and third access port were easily aspirated and flushed with normal saline and the catheter sutured to the skin using 2-0 silk.They did not try to reverse the lines.There was no dimension issue seen and the dimension match what was indicated on the label.It was not repaired and tego was not utilized.A luer adapter was placed on all ports except on the blue port where the wire was exiting.The catheter was in place for five (5) days before the patient expired and cardiogenic shock was determined to be the cause of death which was reported to be unrelated to the event and device.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two device.The visual inspection of the device revealed that only the guide wires were received.The guide wires were unraveled and bent.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8646769
• Report Number: 3009211636-2019-00131
• Device Sequence Number: 16625556
• Product Code: NIE
• UDI-Device Identifier: 10884521127968
• UDI-Public: 10884521127968
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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: 04/21/2020
• Device Model Number: 8888101002HP
• Device Catalogue Number: 8888101002HP
• Device Lot Number: 1803700080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 62 YR