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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0469-01
Device Problem Leak/Splash (1354)
Patient Problem Abdominal Pain (1685)
Event Date 01/20/2021
Event Type  Injury  
Manufacturer Narrative
(b)(6).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).
 
Event Description
It was reported that the patient is in the icu and the customer reports blood in the helium tubing observed 5 minutes earlier.He reports that the patient is complaining of new onset abdominal pain.A physician has been called to remove the iab.Advised that he could disconnect the balloon from the pump and power it down.Blood has not reached the pump.Upon followup in the am, the charge nurse reports that the balloon was removed, and another has not been placed.At this time it is unknown if there is to be another iab placed.
 
Event Description
It was reported that the patient is in the icu and the customer reports blood in the helium tubing observed 5 minutes earlier.He reports that the patient is complaining of new onset abdominal pain.A physician has been called to remove the iab.Advised that he could disconnect the balloon from the pump and power it down.Blood has not reached the pump.Upon followup in the am, the charge nurse reports that the balloon was removed, and another has not been placed.At this time it is unknown if there is to be another iab placed.
 
Manufacturer Narrative
Section a updated patient weight.Section h updated health effect ¿ clinical code, health effect ¿ impact codes, component codes and health effect ¿ impact codes.Reference complaint#: (b)(4).
 
Event Description
It was reported that the patient is in the icu and the customer reports blood in the helium tubing observed 5 minutes earlier.He reports that the patient is complaining of new onset abdominal pain.A physician has been called to remove the iab.Advised that he could disconnect the balloon from the pump and power it down.Blood has not reached the pump.Upon followup in the am, the charge nurse reports that the balloon was removed, and another has not been placed.At this time it is unknown if there is to be another iab placed.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded with blood on the exterior and interior of the catheter and between the catheter and the returned maquet sheath.The extender tubing was also returned.The product type label on the y-fitting was not present.Two catheter tubing kinks were observed approximately 76.2cm & 74.9cm from the iab tip.The technician attempted to insert a 0.025¿ laboratory guidewire through the inner lumen and was found to be occluded with blood.The technician was able to clear the occlusion.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and extender tubing was performed and a leak was detected on the membrane approximately 1.5cm from the rear seal and measuring approximately 0.06cm in length.The reported problem was most likely triggered by the leak found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark caused by a calcified plaque in the aorta.The evaluation confirmed the reported problem.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint #: (b)(4).
 
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Brand Name
SENSATION 7FR. 34CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key11335065
MDR Text Key232158931
Report Number2248146-2021-00090
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567106755
UDI-Public10607567106755
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/01/2022
Device Model Number0684-00-0469-01
Device Catalogue Number0684-00-0433
Device Lot Number3000107898
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2021
Date Manufacturer Received04/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age72 YR
Patient Weight66
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