MAUDE Adverse Event Report: DATASCOPE CORP., SENSATION PLUS 7.5FR 40CC IAB; INTRA-AORTIC BALLOON CATHETER

Model Number 0684-00-0567

Device Problem Alarm, audible (1010)

Patient Problem Death (1802)

Event Date 03/23/2014

Event Type  Death  

Event Description

The facility reported having an optical sensor alarm during therapy.The fiber optic cable was unplugged and re-zeroed, however, they continued to receive the alarm.The pump was turned off and restarted, however, the unit continued to alarm.The fiber-optic cable was then disconnected and a central aortic line was connected to the pump as an alternative pressure source.The pt was stable at this time.It was later reported that the pt expired, however, it was not related to this event.

Manufacturer Narrative

The device was returned for evaluation and decontaminated prior to testing.Visual examination found two kinks in the catheter tubing approximately 39.6cm and 76.2cm from the tip, however, the fiber optic was not damaged.A sensor output test was performed, which tests the ability of the fiber optic sensor to accurately read pressure signals at different intervals.It was found that the fiber optic sensor was operating per specifications.Device history records were also reviewed and no non-conformances were found related to this event.Based on the results of the investigation, we were unable to confirm the reported issues as the returned device operated per specifications.(b)(4).

• Brand Name: SENSATION PLUS 7.5FR 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 07004-0011 ; 9737097256
• MDR Report Key: 3828928
• MDR Text Key: 4448176
• Report Number: 2248146-2014-00069
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2017
• Device Model Number: 0684-00-0567
• Device Catalogue Number: 0684-00-0568-01
• Device Lot Number: 3048
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/31/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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: 71 YR
• Patient Weight: 57