MAUDE Adverse Event Report: DATASCOPE, CORP LINEAR 7.5FR. 34CC IAB; INTRA-AORTIC BALLOON

Model Number 0684-00-0474

Device Problem Invalid Sensing (2293)

Patient Problem Death (1802)

Event Date 07/25/2012

Event Type  Death  

Event Description

While in the rapid gas loss alarm frequently sounded.There was no indication of rupture.At times position change would decrease the interval of time between alarms.After calling the help desk the staff was told to decrease the balloon inflation to 80 percent and put the pump on 1:2.This significantly decreased the alarms to a very minimum.We are returning the balloon (awaiting a speciality bag per your help desk) for further inspection.This was not an isolated incident of this nature.This has occurred on two other patients with the same alarms.Each time the machines were switched out and checked by clinical engineering department.All connections (in each case) were checked and rechecked with no indication of being loose or off.Indication for iabp: post cardiac arrest following aortic valve replacement.

Manufacturer Narrative

Product condition received: the product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.The returned sheath was over the catheter and partially covering the rear portion of the balloon.Three kinks were found, on one the inner lumen approximately 21.6cm from the iab tip and the other on the catheter tubing 42.4cm and 75.9cm from the iab tip.Product evaluation: an underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle.The iab pump normally and no alarm sounded from the pump.Conclusion: the reported problem could not be duplicated during testing.We are unable to determined when the kinks occurred, however if the kinks occurred during the procedure it could restrict the gas flow through the iab which could cause the report alarm.A review of the device history does not indicate any lot specific issues.(b)(4).

• Brand Name: LINEAR 7.5FR. 34CC IAB
• Type of Device: INTRA-AORTIC BALLOON
• Manufacturer (Section D): DATASCOPE, CORP; fairfield NJ
• Manufacturer Contact: jason de sousa ; 15 law dr.; fairfield, NJ 07004 ; 9737097256
• MDR Report Key: 3947330
• MDR Text Key: 4646538
• Report Number: 2248146-2014-00241
• 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: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/08/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2014
• Device Model Number: 0684-00-0474
• Device Catalogue Number: 0684-00-0479-01
• Device Lot Number: 2609
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/15/2012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2011
• 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: 69 YR
• Patient Weight: 98