MAUDE Adverse Event Report: TELEFLEX MEDICAL ARROW ARTERIAL LINE KIT; PERCUTANEOUS ATRIAL CATHETER KIT

Catalog Number AK-04510-S

Device Problems Positioning Failure (1158); Failure to Advance (2524)

Patient Problem No Information (3190)

Event Date 07/16/2014

Event Type  malfunction  

Event Description

Physician was placing a right femoral arterial line, able to access artery but had difficulty advancing wire into needle, so inserted other end of wire.When placing catheter over wire unable to advance catheter, attempted numerous times without sucess.Took a second kit with different wire and able to complete procedure.There was another incident with the same senero the following day.

• Brand Name: ARROW ARTERIAL LINE KIT
• Type of Device: PERCUTANEOUS ATRIAL CATHETER KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; p o box 12600; durham NC 27709
• MDR Report Key: 3973158
• MDR Text Key: 4632394
• Report Number: 3973158
• Device Sequence Number: 1
• Product Code: DQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: AK-04510-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1