MAUDE Adverse Event Report: DATASCOPE CORP LINEAR 7.5 FR 40CC IAB; INTRA-AORTIC BALLOON

Model Number 0684-00-0475

Device Problems Alarm, audible (1010); Balloon leak(s) (1052)

Patient Problem Death (1802)

Event Date 02/24/2011

Event Type  Death  

Event Description

"check iab catheter" alarm sounded from the pump.The tubing was clear and there was no evidence of an iab leak.All connections were tight and placement was at the third rib and below the carina.There were no kinks in the catheter or at the insertion site.Later, flakes of blood were noted in the helium tubing.Datasheet reported; pt in cardiogenic shock and needed cabg.Pt also had ventricular septal defect that needed to be repair.Iab inserted bedside in coronary care unit.Per datasheet: deceased post cabg - (b)(6) 2011.

Manufacturer Narrative

Product condition received.The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath.The extender tubing was also returned.Product evaluation.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and one leak was detected on the rear seal of the membrane.Conclusion: although we cannot determine how it occurred, a leak was found at the rear seal which caused the reported complaint.Internal file number: (b)(4).

• Brand Name: LINEAR 7.5 FR 40CC IAB
• Type of Device: INTRA-AORTIC BALLOON
• Manufacturer (Section D): DATASCOPE CORP; fairfield NJ
• Manufacturer Contact: jason sousa ; 15 law dr.; fairfield, NJ 07004 ; 9737097256
• MDR Report Key: 3885492
• MDR Text Key: 4650914
• Report Number: 2248146-2014-00106
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2013
• Device Model Number: 0684-00-0475
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 2499
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/05/2011
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2010
• 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: 56 YR
• Patient Weight: 86