MAUDE Adverse Event Report: TELEFLEXMEDICAL ARROW; SYSTEM, BALLOON,INTRA-AORTIC, CATHETER

Device Problems Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954)

Patient Problem No Information (3190)

Event Date 11/19/2016

Event Type  malfunction  

Event Description

The iabp placed fiberoptic did not work properly.Blood was found in the gas line.

• Brand Name: ARROW
• Type of Device: SYSTEM, BALLOON,INTRA-AORTIC, CATHETER
• Manufacturer (Section D): TELEFLEXMEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 6213414
• MDR Text Key: 63557186
• Report Number: 6213414
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other