MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number IPN038101

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Gas/Air Leak (2946); Migration (4003)

Patient Problem Blood Loss (2597)

Event Date 08/22/2019

Event Type  Injury  

Event Description

Intra-aortic balloon pump (iabp) started to alarm "helium loss".The alarm was stopped, and the balloon was restarted.It then alarmed 5 more times, all with "helium loss" alarms.After the fourth alarm the resource nurse was at the bedside, i stopped the iabp, nurse disconnected the helium line, cleaned the connection with an alcohol swab and reconnected it.I then restarted the iabp.10 minutes later it alarmed for the 5th time, upon looking at the iabp waveform on the monitor i noticed it was rounded and dampened.I went to the right groin to aspirate and flush the central lumen and heard the iabp helium alarm.Looked at the catheter itself and saw blood in the iabp catheter.I immediately turned off the iabp, turned the central lumen transducer off to the patient, and then noted a small amount of blood in the helium tubing at the "y" connection near the balloon.The helium line was clamped, and the surgical team was notified.The surgical team removed the iabp at the bedside.Another 20 minutes later, the iabp was out of the patient.It was noted upon iabp removal that the tip was missing from the balloon.The patient had imaging studies performed and the retained tip was located over the left femoral region.The patient was taken back to the operating room by the surgical team for removal of this retained object.

• Brand Name: ARROW
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville road; reading PA 19605
• MDR Report Key: 9069613
• MDR Text Key: 158629981
• Report Number: 9069613
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2019,08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN038101
• Device Catalogue Number: IAB-05830-LWS
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 26280 DA
• Patient Weight: 64