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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0576-01
Device Problem Migration (4003)
Patient Problem Pain (1994)
Event Date 08/17/2021
Event Type  Injury  
Manufacturer Narrative
Complete reporter name: (b)(6). The product has been returned to the manufacturer, but is pending investigation. Once the investigation is completed a supplemental report with our findings will be submitted. Complaint record id # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated a check iab catheter alarm. It was discovered that the iab had been dislodged. It was noted that a physician had removed a venous pacing wire from the right groin and while he was removing it, he had somehow grabbed and partially removed the iab catheter from the right femoral. This is when the alarm sounded. They were unable to advance the iab again. The iab tip was not visible on chest film and they then decided to remove the iab catheter. They did not have difficulty removing the iab. The patient began to experience "right flank pain" after removal of the balloon catheter. The pain was newly onset at the time of the pacing wire removal and with attempt to reposition iab catheter. The pain resolved after removal of iab catheter and sheath. The patient was on eptifibatide and heparin infusions at the time of pacing wire removal, but off for brief period (less than 20 minutes) prior to iab removal. Heparin and eptifibatide infusions restarted 2 to 3 hours after iab removal. There was no indication of hematoma, hemorrhage, or retroperitoneal bleed from diagnostic testing nor clinical evaluation. No blood transfusions nor vascular interventions. The patient was discharged and sent home.
 
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Brand NameSENSATION PLUS 8FR. 50CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer Contact
brian schaeffer
15 law drive
fairfield, NJ 
MDR Report Key12435364
MDR Text Key270202239
Report Number2248146-2021-00582
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0576-01
Device Catalogue Number0684-00-0575
Device Lot Number3000140637
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/07/2021 Patient Sequence Number: 1
Treatment
VENOUS PACING WIRE / PACEMAKER
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