MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. FIBEROPTIX ULTRA 8; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number IAB-05840-LWS

Device Problems Material Rupture (1546); Physical Resistance (2578)

Patient Problems Chest Pain (1776); Hemorrhage/Bleeding (1888); Mitral Regurgitation (1964); Myocardial Infarction (1969); Thrombus (2101); Stenosis (2263)

Event Date 07/11/2013

Event Type  Injury  

Event Description

Patient underwent cardiac catheterization and had an intra-aortic balloon pump (iabp) inserted in setting of a non-st-elevation myocardial infarction.Approximately 4 hours after insertion, the ccu nurse noted flecks of blood in the iabp tubing indicating balloon rupture.Helium was purged and the tubing was clamped.Attempts were made at the bedside to remove the catheter but resistance was encountered and the attempts were immediately stopped.Vascular surgery was consulted and the patient was taken to the operating room for a right groin exploration, removal of iabp, and repair of right external iliac artery.The patient was an elderly man with an extensive medical and cardiac history including end stage renal disease, atrial fibrillation, mitral valve insufficiency, aortic valve insufficiency and severe coronary artery disease requiring revascularization last year and again several months ago.He presented with chest pain and was found to have a non-st-elevation myocardial infarction.He underwent a cardiac catheterization, coronary angiogram and insertion of iabp via right femoral artery.He was found to have severe recurrent restenosis of his left anterior descending and left circumflex artery, and severe mitral regurgitation.At the time of the rupture of the iab, the patient began to experience cardiac and pulmonary decompensation.He was intubated and vasoactive medications were initiated.He was brought emergently to the or where he coded twice prior to the beginning of the case but was successfully resuscitated.The iab was found to be impacted in the distal aorta.Tpa was instilled into the balloon to soften the thrombus present.Surgical removal was initiated.The catheter was successfully removed and repair was completed.The patient coded at the end of the case as the skin was being closed and at the request of the family, no further resuscitation efforts were initiated.

• Brand Name: FIBEROPTIX ULTRA 8
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.; 16 elizabeth dr.; chelmsford MA 01824
• MDR Report Key: 5846198
• MDR Text Key: 51152338
• Report Number: 5846198
• 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: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: IAB-05840-LWS
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16F0027
• Other Device ID Number: 8FR/40CC FIBEROPTIX IAB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2016
• 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
• Treatment: CARDIAC DRUGS
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 72