MAUDE Adverse Event Report: TELEFLEX / ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED) AC3 OPTIMUS IABP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number IAP0700

Device Problems Material Rupture (1546); Defective Component (2292); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, event description (balloon rupture): iabp alarming "helium loss 3." after troubleshooting by multiple rns, teleflex rep (b)(4) was contacted.After troubleshooting with the rep, she said that most likely the balloon has a small abrasion and needs to be removed or exchanged within 30 minutes.Pump stopped.Cardiology fellow notified and contacted interventional cardiology.Per rep, catheter should be saved and sent for testing.Reference reports mw5117820, mw5117821, mw5117822, mw5117824, mw5117825, mw5117826, mw5117827.

• Brand Name: AC3 OPTIMUS IABP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): TELEFLEX / ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED); morrisville NC 27560
• MDR Report Key: 17002066
• MDR Text Key: 316019610
• Report Number: MW5117823
• Device Sequence Number: 1
• Product Code: DSP
• 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: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IAP0700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other