MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PSI KIT: 9 FR; INTRODUCER CATHETER

Catalog Number AK-09903-CDC

Device Problems Material Separation (1562); Physical Resistance/Sticking (4012)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report# mw5087615.Additional information requested from the user facility.No additional information received at the time of this report.

Event Description

According to the maude report "anesthesiologist used steeper angle and got good blood flow in the ij.Wire threaded easily.Ultrasound showing wire in ij.The crna threaded the cordis over the wire with slight resistance.Upon trying to remove the wire from the introducer, the wire was unraveling.There was little resistance , but it kept unraveling as it was pulled out.Since the wire unraveled there was concern that a part of the wire could still be intravascular.Ultrasound was used to look at the vessel.No district signs of the wire but there was something flapping in the vessel which may be a vascular injury.No hematoma in the neck and vessel looks overall intact.Discussed case with cv surgeon and ir.Decision made to do a ct of the chest and neck, introducer was sutured in place, ct revealed retained guidewire and decision made for ir procedure to remove wire".

Manufacturer Narrative

Qn#(b)(4).Mdr report key# 8735248.Report# mw5087615.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and 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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

According to the maude report "anesthesiologist used steeper angle and got good blood flow in the ij.Wire threaded easily.Ultrasound showing wire in ij.The crna threaded the cordis over the wire with slight resistance.Upon trying to remove the wire from the introducer, the wire was unraveling.There was little resistance , but it kept unraveling as it was pulled out.Since the wire unraveled there was concern that a part of the wire could still be intravascular.Ultrasound was used to look at the vessel.No district signs of the wire but there was something flapping in the vessel which may be a vascular injury.No hematoma in the neck and vessel looks overall intact.Discussed case with cv surgeon and ir.Decision made to do a ct of the chest and neck, introducer was sutured in place, ct revealed retained guidewire and decision made for ir procedure to remove wire".

• Brand Name: ARROW PSI KIT: 9 FR
• Type of Device: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8841042
• MDR Text Key: 152630537
• Report Number: 9680794-2019-00270
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K780532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: AK-09903-CDC
• Device Lot Number: 13F19A0303
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORDIS CATHETER; CORDIS CATHETER; CORDIS CATHETER
• Patient Outcome(s): Life Threatening; Other; Required Intervention