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

Model Number 0684-00-0433

Device Problems Difficult to Insert (1316); Material Protrusion/Extrusion (2979)

Patient Problems Bradycardia (1751); Death (1802); Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130)

Event Date 09/26/2013

Event Type  Death  

Event Description

It was reported that the physician had difficulty inserting the guidewire into the angiographic needle.The wire was switched with one from another kit and therapy resumed.It was reported the guidewire looked incomplete, with the outer winding protruding from the side of the guidewire.The pt received aortic valve replacement earlier in the day and returned to the operating room for decreased blood pressure and heart rate.The intra-aortic balloon catheter was inserted, however the pt had a vfib arrest and was pronounced dead at 20:20 in the operating room.

Manufacturer Narrative

The intra-aortic balloon catheter was returned for evaluation on (b)(4) 2013 and sent for decontamination prior to testing.The guide wire was returned inside its protective tubing with the j-straightener attached.Visual examination of the guidewire was performed and the j-tip was found to be damaged.Although the guidewire was found to be damaged, we are unable to determine how or when this occurred.A review of device history records did not show any non-conformities which could have caused or contributed to this event.Additionally all iabs are 100% inspected prior to shipping, therefore any damage of this nature would have been identified.

• Brand Name: SENSATION 7FR. 34CC 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: 3708628
• MDR Text Key: 20328090
• Report Number: 2248146-2014-00046
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/21/2001

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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?: No
• Date Returned to Manufacturer: 12/10/2013
• Is the Reporter a Health Professional?: Yes
• 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: 76 YR
• Patient Weight: 25