MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW 3-L CVC KIT: 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CDC-45703-1A

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).Mdr report key#: (b)(4) /mdr text key#: (b)(4).Report number#: mw5098133.

Event Description

According to the maude report (mdr report key# (b)(4).Mdr text key# (b)(4).Report number# mw5098133) "during insertion of central line, wire was advanced with resistance, so wire was refracted; during retraction, resistance was felt, and wire was removed with difficulty; a section of the wire remained in the patient; cxr: 15 mm linear foreign body in the left supraclavicular region.Information from the attending physician: he thought the guidewire was sheared by the introducer needle indicating failure of the guidewire's structural integrity; he believed that plaque formation on the vessel created a barrier to entry into the vein causing the guidewire to deflect off the vessel and into the sq tissue; it most likely entered fibrotic tissue that caused resistance when the procedures tried to retract the guidewire".

Manufacturer Narrative

Qn#b)(4).Mdr report key# 10919190/mdr text key# 218981131.Report number# mw5098133.Complaint verification testing could not be performed as it was reported that the sample is not available for return.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

According to the maude report (mdr report key# 10919190/mdr text key# 218981131/report number# mw5098133) "during insertion of central line, wire was advanced with resistance, so wire was refracted; during retraction, resistance was felt, and wire was removed with difficulty; a section of the wire remained in the patient; cxr: 15 mm linear foreign body in the left supraclavicular region.Information from the attending physician: he thought the guidewire was sheared by the introducer needle indicating failure of the guidewire's structural integrity; he believed that plaque formation on the vessel created a barrier to entry into the vein causing the guidewire to deflect off the vessel and into the sq tissue; it most likely entered fibrotic tissue that caused resistance when the procedures tried to retract the guidewire".

• Brand Name: ARROW 3-L CVC KIT: 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11139522
• MDR Text Key: 227748419
• Report Number: 9680794-2021-00015
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K993691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: CDC-45703-1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1