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

Model Number IPN915317

Device Problem Material Rupture (1546)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/27/2021

Event Type  Injury  

Event Description

Patient in cicu (cardiac intensive care unit) with iabp (intra-aortic balloon pump) after cardiac cath procedure 2 days earlier.Helium loss alarms began at approximately 1800, blood noted in helium tubing.The attending md intensivist, resident, and perfusionist were at bedside confirmed iabp rupture.The patient's bp initially stable with pump off but shortly after became hypotensive requiring iv infusions of epinephrine and levophed.The attending md met difficulty with removing the iabp catheter.Vascular surgery called to bedside and was able to successfully extract iabp with sheath without any difficulties within 15 minutes.Patient's bp down trending and family called to come to bedside.Patient died within the hour of removal of iabp.Manufacturer response for system, balloon, intra-aortic and control, arrow (per site reporter).

Event Description

Patient in cicu (cardiac intensive care unit) with iabp (intra-aortic balloon pump) after cardiac cath procedure 2 days earlier.Helium loss alarms began at approximately 1800, blood noted in helium tubing.The attending md intensivist, resident, and perfusionist were at bedside confirmed iabp rupture.The patient's bp initially stable with pump off but shortly after became hypotensive requiring iv infusions of epinephrine and levophed.The attending md met difficulty with removing the iabp catheter.Vascular surgery called to bedside and was able to successfully extract iabp with sheath without any difficulties within 15 minutes.Patient's bp down trending and family called to come to bedside.Patient died within the hour of removal of iabp.Manufacturer response for system, balloon, intra-aortic and control, arrow (per site reporter).

• Brand Name: ARROW
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 13174933
• MDR Text Key: 283319014
• Report Number: 13174933
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915317
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F21H0047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 33945 DA
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Race: Black Or African American