MAUDE Adverse Event Report: ARROW ARROW; MAC DOUBLE LUMEN CATHETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Rash (2033); Tachycardia (2095)

Event Date 01/04/2017

Event Type  Injury  

Event Description

Patient presented for mini mr, pmh severe mr, mvp, mild asthma, htn, hld, nstemi in 2012, nkda, latex allergic, anesthesia induction/intubation without incident.A 9f double lumen catheter inserted in rij, with quick hypotension, tachycardia, facial rash.Catheter removed, treated with epinephrine, vasopressin, benadryl, hydrocortisone.Tryptase elevated.Case cancelled.Catheter checked- latex free.+chg coated, silver sulfadine.

• Brand Name: ARROW
• Type of Device: MAC DOUBLE LUMEN CATHETER
• Manufacturer (Section D): ARROW
• MDR Report Key: 6307715
• MDR Text Key: 66811372
• Report Number: MW5067711
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/03/2017

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 59 YR
• Patient Weight: 66