MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; WIRE, GUIDE, CATHETER

Model Number	IPN036230
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
This report is regarding the placement of a right femoral hemodialysis (hd) line.Summary: wire sheared upon removal through catheter.While the vein was being accessed using bedside ultrasound in the critical care unit, the wire was fed into needle without issue.The needle was then removed.The catheter was placed confirmed using manometry over a flexible wire.The wire was removed.Venous blood was confirmed on manometry [based upon the pressure].The wire was reintroduced into the femoral vessel through the manometry catheter.The wire placement was confirmed with ultrasound.Soft tissue was dilated x 2.The hd catheter was placed over wire.When the wire was attempted to be pulled back, there was resistance.The operator tried to change the angle.There was still resistance.Consequently, the catheter was pulled out halfway out of the vessel with wire remaining inside the catheter.Next, the wire was pulled back and was noted to be sheared.The wire could not be pulled back further.In entirety, the catheter and wire were removed.The tip of the wire was still intact, and the middle of the wire had been sheared.A second wire was used to place a catheter using the same access site without issue.A kidney, ureter, and bladder (kub) x-ray was obtained and no residual wire was identified (not thought to have been broken off at all).The packing for the wire used is attached.The packaging of the hd line that was successfully placed is attached.The packaging of the hd line that was not placed in which the wire was stuck was disposed of prior to obtaining imaging (believed to all be the same lot).

• Brand Name: ARROW
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 10648168
• Report Number: 10648168
• Device Sequence Number: 17057784
• Product Code: DQX
• UDI-Device Identifier: 10801902122534
• UDI-Public: (01)10801902122534(17)250228(10)14F20B0223
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2020
• Report Date (Section F): 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN036230
• Device Catalogue Number: AW-14735
• Device Lot Number: 14F20B0223
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/28/2020