MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW VASCULAR UNKNOWN; CATHETER, PERCUTANEOUS

Catalog Number VASCULAR UNKNOWN

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Device Embedded In Tissue or Plaque (3165)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the medwatch "during liver transplant surgery, a rapid infusion iv catheter was placed in the right arm and used during a massive transfusion protocol and subsequent blood transfusions.On (b)(6), in the icu, the patient was noted to be in supraventricular tachycardia and hypotensive.Acls protocol was initiated with adenosine and calcium chloride given through the rapid infusion iv catheter was noted to have infiltrated.The line was removed.It was found that the introducer/dilator used to place the line had not been removed and was still inside the rapid infusion iv catheter".The user error has been addressed by sending out rapid infusion catheter educational information to anesthesia providers, including anesthesiologists, crnas, fellows and residents.

Manufacturer Narrative

Qn#(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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

According to the medwatch "during liver transplant surgery a rapid infusion iv catheter was placed in the right arm and used during a massive transfusion protocol and subsequent blood transfusions.On april 6, in the icu, the patient was noted to be in supraventricular tachycardia and hypotensive.Acls protocol was initiated with adenosine and calcium chloride given through the rapid infusion iv catheter was noted to have infiltrated.The line was removed.It was found that the introducer/dilator used to place the line had not been removed and was still inside the rapid infusion iv catheter".The user error has been addressed by sending out rapid infusion catheter educational information to anesthesia providers, including anesthesiologists, crnas, fellows and residents.

• Brand Name: ARROW VASCULAR UNKNOWN
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8834670
• MDR Text Key: 152671072
• Report Number: 9680794-2019-00287
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• 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: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VASCULAR UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 96