MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR 40CC IAB; INTRA-AORTIC BALLOON CATHETER

Model Number 0684-00-0434

Device Problems Material Rupture (1546); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944)

Patient Problems Bradycardia (1751); Death (1802); Occlusion (1984)

Event Date 01/13/2014

Event Type  Death  

Event Description

The patient arrived in the emergency department at 7am on (b)(6) 2014, with a ventricular escape rhythm.She was placed on dopamine drip and a cardiology consult was ordered.Patient was responsive and heart rate increased from 27 initially, into the 60-70 range, in a junctional rhythm.Troponins came back positive.Cardiologist scheduled the patient for noon and the patient was already acidotic.Diagnostic left heart catheterization demonstrated total occlusion of proximal right coronary artery including the sa and av nodal arteries.A drug eluting stent was placed ostially.Intra-aortic balloon was placed prior to percutaneous coronary intervention as the patient's blood pressure was in the 80's and was being fluid resuscitated.Patient was transported to intensive care unit department in critical but stable condition with augmented pressures in the 100-110 range on 1:1.Patient was alert and pain free.Bicarb was administered in the cath lab.There was good augmentation and "chair" waveform with great reduction in afterload "assisted and unassisted systole more than 20mmhg." intensive care unit staff called cath lab several times with concerns over blood pressure and eventually at 5pm, the iabp "was not working properly." upon inspection, the alarm did not state "gas loss" but said "check catheter." hospital staff observed brown flecking in the tubing.After assessing the groin site and checking for a kinked catheter, the iabp was started again and there was no augmented waveform arterially.The physician was notified that we likely had a ruptured balloon and it was removed.Inspection of the iabp balloon shows rust colored material in the proximal section of the balloon.Datasheet reported patient expired on (b)(6) 2014, at 7:30am, however, there was no injury or patient death resulting from the event.

Manufacturer Narrative

The intra-aortic balloon catheter was returned for evaluation on (b)(4) 2014 and sent for decontamination prior to testing.A 4psi underwater leak test was performed on the device and a leak was found on the membrane approximately 1.8cm from the rear seal, measuring 0.013cm in length.Examination of the leak site under a microscope revealed a rough white patch around the penetration, indicating that this was an abrasion leak.Abrasion leaks typically occur when calcified plaque in the aorta wears away at the membrane material after several hours of pumping.This is not an unexpected outcome of iab therapy.A hospital representative reported that the death of this patient was not attributed to the product.

• Brand Name: SENSATION 7FR 40CC IAB
• Type of Device: INTRA-AORTIC BALLOON CATHETER
• Manufacturer (Section D): DATASCOPE CORP.; fairfield NJ
• Manufacturer Contact: jason sousa ; 15 law dr.; fairfield, NJ 07004 ; 9737097256
• MDR Report Key: 3649682
• MDR Text Key: 4320908
• Report Number: 2248146-2014-00009
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2016
• Device Model Number: 0684-00-0434
• Device Catalogue Number: 0684-00-0470-01
• Device Lot Number: 2996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2014
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Weight: 95