MAUDE Adverse Event Report: MEDICAL COMPONENTS INC 14F X 40CM SPLIT CATH III; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number ASPC40-3

Device Problems Failure to Advance (2524); Physical Resistance (2578)

Patient Problems Death (1802); Erythema (1840); Exsanguination (1841); Occlusion (1984); Pneumothorax (2012); Low Oxygen Saturation (2477); Cognitive Changes (2551); Blood Loss (2597)

Event Date 01/05/2017

Event Type  Death  

Event Description

The patient's tunneled dialysis catheter was malfunctioning so she presented to the or for exchange of the catheter in the right internal jugular vein.From the operative report: the patient's teflon cuff was easily exposed and was not at all adherent.There was leakage of cloudy fluid from the exit site.There was a small amount of erythema.I was concerned that this was an infected exit site and the same tunnel could not be used for simple exchange over wires.A counter-incision was made at the apex of the indwelling catheter, at the base of the neck.The catheter was carefully dissected out.A mosquito clamp was placed on the catheter at this level.The catheter was then transected at the level of the teflon cuff and positioned as if it was an antegrade puncture into the jugular vein.Two 0.035 stiff angled glidewires were manipulated into the inferior vena cava under fluoroscopy.This was secured with a mosquito clamp.Next, a new 28 cm, 14-french catheter was prepped.A new counter-incision was made on the anterior chest wall after a new tunnel had been anesthetized.The catheter was taken from the anterior chest wall to the internal jugular vein access site.The tunneling device was removed.The dilator and peel-away sheath, which came with the line, was advanced over a stiff angled glidewire under fluoroscopy.The sheath met some resistance; several centimeters from where it entered the skin.The glidewire had retracted some.I attempted to advance the glidewire, but it would not advance into the superior vena cava at this time.The glidewire was backed out and attempted to be manipulated into the superior venacava, but would only enter the left and right subclavian veins.I removed the wire and injected the sheath with contrast.The contrast did not exit this site readily.It appeared that there was occlusion of the superior vena cava.I made further attempts at manipulating the wire into the superior vena cava, but it would not go.At this time, the patient became a bit restless.She was receiving monitored anesthesia care and could not answer how she was doing.The patient began to have some desaturation of her oxygenation.The fluoroscopic images were studied, and it appeared that the lung parenchyma was being pushed towards the mediastinum.I had concern that she had a pneumothorax, despite not having made a new puncture.We called for the trauma surgery service to come and evaluate.The patient was intubated.She was requiring pressor support.Needle decompression was attempted in the right chest.This did not result in a large rush of air.At this point, trauma entered the room.Cardiac surgeon called to the room.The chest tube was placed, and there was return of approximately 400 to 500 ml of blood, which was dark.The chest tube was studied, and the lung continued to be somewhat compressed.The chest tube was not draining any more blood.A 2nd chest tube was placed.This resulted in some more evacuation of hematoma.Continued attempts to find the source of bleeding were unsuccessful.Resuscitation efforts were also ultimately unsuccessful.

Event Description

The patient's tunneled dialysis catheter was malfunctioning so she presented to the or for exchange of the catheter in the right internal jugular vein.From the operative report: the patient's teflon cuff was easily exposed and was not at all adherent.There was leakage of cloudy fluid from the exit site.There was a small amount of erythema.I was concerned that this was an infected exit site and the same tunnel could not be used for simple exchange over wires.A counter-incision was made at the apex of the indwelling catheter, at the base of the neck.The catheter was carefully dissected out.A mosquito clamp was placed on the catheter at this level.The catheter was then transected at the level of the teflon cuff and positioned as if it was an antegrade puncture into the jugular vein.Two 0.035 stiff angled glidewires were manipulated into the inferior vena cava under fluoroscopy.This was secured with a mosquito clamp.Next, a new 28 cm, 14-french catheter was prepped.A new counter-incision was made on the anterior chest wall after a new tunnel had been anesthetized.The catheter was taken from the anterior chest wall to the internal jugular vein access site.The tunneling device was removed.The dilator and peel-away sheath, which came with the line, was advanced over a stiff angled glidewire under fluoroscopy.The sheath met some resistance; several centimeters from where it entered the skin.The glidewire had retracted some.I attempted to advance the glidewire, but it would not advance into the superior vena cava at this time.The glidewire was backed out and attempted to be manipulated into the superior venacava, but would only enter the left and right subclavian veins.I removed the wire and injected the sheath with contrast.The contrast did not exit this site readily.It appeared that there was occlusion of the superior vena cava.I made further attempts at manipulating the wire into the superior vena cava, but it would not go.At this time, the patient became a bit restless.She was receiving monitored anesthesia care and could not answer how she was doing.The patient began to have some desaturation of her oxygenation.The fluoroscopic images were studied, and it appeared that the lung parenchyma was being pushed towards the mediastinum.I had concern that she had a pneumothorax, despite not having made a new puncture.We called for the trauma surgery service to come and evaluate.The patient was intubated.She was requiring pressor support.Needle decompression was attempted in the right chest.This did not result in a large rush of air.At this point, trauma entered the room.Cardiac surgeon called to the room.The chest tube was placed, and there was return of approximately 400 to 500 ml of blood, which was dark.The chest tube was studied, and the lung continued to be somewhat compressed.The chest tube was not draining any more blood.A 2nd chest tube was placed.This resulted in some more evacuation of hematoma.Continued attempts to find the source of bleeding were unsuccessful.Resuscitation efforts were also ultimately unsuccessful.

• Brand Name: 14F X 40CM SPLIT CATH III
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MEDICAL COMPONENTS INC
• MDR Report Key: 6692381
• MDR Text Key: 79250106
• Report Number: 6692381
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2017,07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/26/2019
• Device Model Number: ASPC40-3
• Device Lot Number: MHWB960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT AT THE TIME OF THE EVENT. OTHER LIFE-SAVING ME
• Patient Outcome(s): Death
• Patient Age: 76 YR
• Patient Weight: 91