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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0567
Device Problem Material Rupture (1546)
Patient Problem Unspecified Infection (1930)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to the manufacturer however at this time, it has been sent out for sanitization and we're unable to complete an evaluation on the affected product. When the product returns and an assessment of the affected product is complete a supplemental report with our additional findings will be provided. (b)(4).
 
Event Description
The nurse reported a balloon rupture. The patient was reported to have a wound vac due to an infection at the insertion site.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter. The extension and pressure tubing were also returned. One kink was found on the catheter tubing near the y-fitting approximately 76. 5cm from the iab tip. An optical fiber break and penetration was observed at this location. An underwater leak test of the balloon, catheter, y-fitting, extracorporeal, extension and pressure tubing was performed and a leak was confirmed on the catheter tubing. The penetration found in the catheter tubing appears to have been caused by a severe kink flexing back and forth that eventually penetrated the tubing causing the reported problem. (b)(4).
 
Event Description
The nurse reported a balloon rupture. The patient was reported to have a wound vac due to an infection at the insertion site.
 
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Brand NameSENSATION PLUS 7.5FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key6060055
MDR Text Key58501390
Report Number2248146-2016-00087
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/11/2019
Device Catalogue Number0684-00-0567
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received10/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/27/2016 Patient Sequence Number: 1
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