MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR 40CC IAB; INTRA-AORTIC BALLOON CATHETER

Model Number 0684-00-0434

Device Problem Alarm, audible (1010)

Patient Problem Surgical procedure, repeated (2042)

Event Date 05/06/2014

Event Type  Injury  

Event Description

The customer reported receiving a "leak in iab circuit" alarm, followed by an "autofill failure" alarm.The possible causes were checked.No blood was seen in the catheter tubing, all connections were tight and the helium tank was full.The pump was changed and the alarms persisted.The balloon had been immobile for 10 minutes when the customer was reminded that the device should not go past 30 minutes with immobility.The physician ordered a chest x-ray as the iab was placed into an axillary insertion site.The customer called later to report that the patient went into surgery and the iab was replaced.The event was not attributed to the device.

Manufacturer Narrative

The device is promised for return, but has not yet been received.When the device is returned or additional information received, a supplemental report will be submitted.Internal complaint (b)(4).

• Brand Name: SENSATION 7FR 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 ; 9737097256
• MDR Report Key: 3876005
• MDR Text Key: 4461511
• Report Number: 2248146-2014-00085
• 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
• Type of Report: Initial
• Report Date: 05/06/2014

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: 12/12/2016
• Device Model Number: 0684-00-0434
• Device Catalogue Number: 0684-00-0470-01
• Device Lot Number: 3040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2014
• Initial Date FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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): Required Intervention
• Patient Age: 43 YR