MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 12 FR X 16 CM ANTI; CATHETER, HEMODIALYSIS, NON-I

Catalog Number CDC-22122-X1A

Device Problems Unraveled Material (1664); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Updated information of a patient event received as follows: may 13th was the date of the complication.Patient was found unconscious in a hotel due to overdose.Once ed stabilized the patient, he was placed in micu.Venous access was required but no ij or upper vascular access available.The fellow nephrologist inserted a 12fr acute dialysis catheter through left femoral vein.His report provided by risk management follows: the resident was reported to have placed the spring guide wire at a 90-degree angle which created a kink in the guide wire.He pulled back on the wire through the introducer needle to try another approach.He felt resistance, yet was able to push through.The catheter was inserted over the guide wire with some resistance yet seemed to have feed through and had blood return.Upon removing the guide-wire, he said it was unraveled at the distal end and looked strange but proceeded to complete the dressing and left.The tray w/spring wire guide was thrown away.Patient was sent to dialysis where low flow rates were acquired so the catheter was replaced with another 14fr acute dialysis catheter which it was during this chest x-ray a small 2-3cm object was noticed in the lung.They removed it in ir by a snare procedure and it appeared to be an uncoiled wire.The wire was thrown away.The hospital knows it was user error and the physician received extensive training with their nephrology staff.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Updated information of a patient event received as follows: (b)(6) was the date of the complication.Patient was found unconscious in a hotel due to overdose.Once ed stabilized the patient, he was placed in micu.Venous access was required but no ij or upper vascular access available.The fellow nephrologist inserted a 12fr acute dialysis catheter through left femoral vein.His report provided by risk management follows: the resident was reported to have placed the spring guide wire at a 90-degree angle which created a kink in the guide wire.He pulled back on the wire through the introducer needle to try another approach.He felt resistance, yet was able to push through.The catheter was inserted over the guide wire with some resistance yet seemed to have feed through and had blood return.Upon removing the guide-wire, he said it was unraveled at the distal end and looked strange but proceeded to complete the dressing and left.The tray w/spring wire guide was thrown away.Patient was sent to dialysis where low flow rates were acquired so the catheter was replaced with another 14fr acute dialysis catheter which it was during this chest x-ray a small 2-3cm object was noticed in the lung.They removed it in ir by a snare procedure and it appeared to be an uncoiled wire.The wire was thrown away.The hospital knows it was user error and the physician received extensive training with their nephrology staff.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 12 FR X 16 CM ANTI
• Type of Device: CATHETER, HEMODIALYSIS, NON-I
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9163379
• MDR Text Key: 161790241
• Report Number: 1036844-2019-00976
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: CDC-22122-X1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 10/30/2019
• Supplement Dates FDA Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention