MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH SET: 20 GA X 1-3/4"; WIRE GUIDE CATHETER

Catalog Number RA-04020

Device Problem Obstruction of Flow (2423)

Patient Problems Skin Discoloration (2074); Tissue Damage (2104)

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The risk manager reports that the patient died on 07/27/2018.The risk manager also reports that the doctor that handled the patient's case did not indicate that the a-line complication had any impact on the patient's death in the discharge summary.It is also reported that the a-line used for this patient was discarded, and the information provided was from a similar a-line that is used by the facility.

Event Description

According to the medwatch received (b)(4) "patient came in for a 2-vessel coronary artery bypass.Lines were placed, uneventfully, in the preoperative holding area.Intraoperative, the radial arterial reading declined, adjustments were made to correct a positional issue with no improvement.Anesthesia discontinued use of the radial arterial line at the first sign of issues.A femoral line was placed, also uneventfully.Reading was sufficient from the line.Upon removal of drapes, the arm was severely blistered, and hand was dusky with minimal flow.Surgeon was alerted of the issue and a vascular surgeon was called to the room.The on-call vascular surgeon suggested calling ortho trauma surgeon to do a fasciotomy.Appropriate supplies were gathered, and procedure was done as soon as the surgeon came to the room.Adequate flow was restored to the hand upon doppler reading.Dressings were applied, and patient was transported to the unit".

Event Description

According to the medwatch received (b)(4) "patient came in for a 2-vessel coronary artery bypass.Lines were placed, uneventfully, in the preoperative holding area.Intraoperative, the radial arterial reading declined, adjustments were made to correct a positional issue with no improvement.Anesthesia discontinued use of the radial arterial line at the first sign of issues.A femoral line was placed, also uneventfully.Reading was sufficient from the line.Upon removal of drapes, the arm was severely blistered , and hand was dusky with minimal flow.Surgeon was alerted of the issue and a vascular surgeon was called to the room.The on-call vascular surgeon suggested calling ortho trauma surgeon to do a fasciotomy.Appropriate supplies were gathered , and procedure was done as soon as the surgeon came to the room.Adequate flow was restored to the hand upon doppler reading.Dressings were applied , and patient was transported to the unit".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.

• Brand Name: ARROW RA CATH SET: 20 GA X 1-3/4"
• Type of Device: WIRE GUIDE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7896323
• MDR Text Key: 121448519
• Report Number: 9680794-2018-00185
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K810675
• 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: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RA-04020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR