MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7 FR. 34CC IAB; INTRA-AORTIC BALLOON

Model Number 0684-00-0433

Device Problem Entrapment of Device (1212)

Patient Problem Death (1802)

Event Date 10/11/2012

Event Type  Death  

Event Description

After insertion of the iab catheter via guide wire (without the sheath), the guide wire could not be removed; even after removal of the iab catheter, the wire could not be removed.No fluoroscopy or x-ray used.Updated on (b)(6) 2012.The doctor confirmed that there was no death as a consequence of this failure.In the meantime the pt has died, but this is not related to that failure.

Manufacturer Narrative

The iab was returned with the membrane completely unfolded and the guide wire stuck inside the iab lumen.No kinks were found on the iab catheter.Product evaluation: the returned guide wire was able to be removed from the catheter and was found to be unraveled near the j-tip with dried blood on it.The 0.018" guide wire diameter was measured and found to be within specification.The inner lumen was dimensionally inspected and found to meet specification.Conclusion: the evaluation confirms the reported problem.It appears that the inner lumen became occluded with dried blood while the guide wire was still inside the lumen.This may have caused the guide wire to be difficult to remove from the iab lumen and result in the guide wire unraveling when attempting to remove it.(b)(4).

• Brand Name: SENSATION 7 FR. 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: 3947366
• MDR Text Key: 19402273
• Report Number: 2248146-2014-00143
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2015
• Device Model Number: 0684-00-0433
• Device Catalogue Number: 0684-00-0469-01
• Device Lot Number: 2744
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/29/2012
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2012
• Initial Date FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• 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: 72 YR
• Patient Weight: 70