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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problems Failure to Advance (2524); Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/08/2018
Event Type  Death  
Manufacturer Narrative
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 # (b)(4), record # (b)(4).
 
Event Description
It was reported that an intra-aortic balloon (iab) was inserted through an 8fr sheath with resistance being felt prior to iab being fully inserted.The iab was unable to advance.The iab was removed and a new iab inserted with no difficulty.There was no reported injury to the patient.
 
Manufacturer Narrative
Additional information: customer reported patient death on (b)(6) 2018.Changed from: product problem to: product problem and adverse event.Death and date added.Changed from: it was reported that an intra-aortic balloon (iab) was inserted through an 8fr sheath with resistance being felt prior to iab being fully inserted.The iab was unable to advance.The iab was removed and a new iab inserted with no difficulty.There was no reported injury to the patient.To: it was reported that an intra-aortic balloon (iab) was inserted through an 8fr sheath with resistance being felt prior to iab being fully inserted.The iab was unable to advance.The iab was removed and a new iab inserted with no difficulty.The patient was experiencing acute myocardial infarction (ami) and patient was transferred to a higher level of care via ambulatory services while receiving iab therapy.The patient needed a stent as well as cpr(cardiopulmonary resuscitation) and acls(advanced cardiac life support) medications.Patient was dnr (do-not-resuscitate).The patient expired, but the death is not attributed to the device.This submission is for the 1st iab used.Changed from malfunction to: adverse event.(b)(4).Device evaluation: the product was returned with the membrane completely unfolded and blood on the exterior of the catheter with the one-way valve attached.The sheath was not returned for evaluation.Two kinks were found on the catheter tubing approximately 70.1 cm and 75.9 cm from the iab tip.The one-way valve was vacuum tested and it held vacuum.A laboratory insertion test was unable to be performed due to the membrane being unfurled.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.An evaluation of the product was unable to duplicate the reported problem.The product performed according to specification.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.(b)(4).
 
Event Description
It was reported that an intra-aortic balloon (iab) was inserted through an 8fr sheath with resistance being felt prior to iab being fully inserted.The iab was unable to advance.The iab was removed and a new iab inserted with no difficulty.The patient was experiencing acute myocardial infarction (ami) and patient was transferred to a higher level of care via ambulatory services while receiving iab therapy.The patient needed a stent as well as cpr(cardiopulmonary resuscitation) and acls(advanced cardiac life support) medications.Patient was dnr (do-not-resuscitate).The patient expired, but the death is not attributed to the device.This submission is for the 1st iab used.
 
Manufacturer Narrative
(b)(6).Complaint # (b)(4), record # (b)(4).
 
Event Description
It was reported that an intra-aortic balloon (iab) was inserted through an 8fr sheath with resistance being felt prior to iab being fully inserted.The iab was unable to advance.The iab was removed and a new iab inserted with no difficulty.The patient was experiencing acute myocardial infarction (ami) and patient was transferred to a higher level of care via ambulatory services while receiving iab therapy.The patient needed a stent as well as cpr(cardiopulmonary resuscitation) and acls(advanced cardiac life support) medications.Patient was dnr (do-not-resuscitate).The patient expired, but the death is not attributed to the device.This submission is for the 1st iab used.
 
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Brand Name
SENSATION PLUS 8FR. 50CC IAB
Type of Device
SYSTEM, 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 Key7402104
MDR Text Key104822044
Report Number2248146-2018-00238
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 Other
Type of Report Initial,Followup,Followup
Report Date 06/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/01/2020
Device Catalogue Number0684-00-0575
Device Lot Number3000053156
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2018
Is the Reporter a Health Professional? No
Device AgeYR
Date Manufacturer Received06/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age79 YR
Patient Weight103
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