MAUDE Adverse Event Report: TELEFLEX MEDICAL ARROW RADIAL ARTERY CATH SET; WIRE, GUIDE, CATHETER

Model Number RA-04220

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Insert (1316)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/07/2022

Event Type  Injury  

Event Description

During art line placement, tip of catheter dislodged in soft tissue/artery.Art line was attempted radial and was unsuccessful.Art line was attempted ulnar.After catheter was removed, a piece of "filament' (very small in diameter) wire was sticking out of site.Doctor removed it but a piece remained in the soft tissue and artery.Surgery required to remove.

• Brand Name: ARROW RADIAL ARTERY CATH SET
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 15456063
• MDR Text Key: 300337983
• Report Number: MW5112146
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RA-04220
• Device Lot Number: 14F22D0023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American