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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
Catalog Number 0684-00-0567
Device Problems Calibration Problem (2890); Material Deformation (2976); Pressure Problem (3012)
Patient Problems No Consequences Or Impact To Patient (2199); Heart Failure (2206)
Event Date 10/05/2018
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint # (b)(4), record # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy the customer inserted the iab through the axillary site which is an off-label use and there was a kink at the site.The customer was unable to calibrate and the iab pump (iabp) monitor had a waveform, but no numbers.The customer unplugged and re-plugged in the fiber optic connector and attempted to re-zero, but it did not work.The customer was able to aspirate blood and perform a full 15 second flush after which the customer did note a good waveform and indices.The customer was able to continue therapy successfully.The indication for use was heart failure.There was no reported injury to the patient.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy the customer inserted the iab through the axillary site which is an off-label use and there was a kink at the site.The customer was unable to calibrate and the iab pump (iabp) monitor had a waveform, but no numbers.The customer unplugged and re-plugged in the fiber optic connector and attempted to re-zero, but it did not work.The customer was able to aspirate blood and perform a full 15 second flush after which the customer did note a good waveform and indices.The customer was able to continue therapy successfully.The indication for use was heart failure.There was no reported injury to the patient.
 
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.Reference complaint # (b)(4); record id (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy the customer inserted the iab through the axillary site which is an off-label use and there was a kink at the site.The customer was unable to calibrate and the iab pump (iabp) monitor had a waveform, but no numbers.The customer unplugged and re-plugged in the fiber optic connector and attempted to re-zero, but it did not work.The customer was able to aspirate blood and perform a full 15 second flush after which the customer did note a good waveform and indices.The customer was able to continue therapy successfully.The indication for use was heart failure.There was no reported injury to the patient.
 
Manufacturer Narrative
Section d.Suspect medical device changed serial number (b)(4) to (b)(4).Section d.Suspect medical device changed catalog # 0684-00-0567 to 0684-00-0575.Section d.Suspect medical device changed lot # 3000077564 to 3000088929.Section d.Suspect medical device changed exp date 07/13/2021 to 01/24/2022.Section h.Device manufacturers only changed manufacture date 07/13/2018 to 01/24/2019.Section d.Suspect medical device changed sensation plus 7.5fr.40cc iab to sensation plus 8fr.50cc iab.The facility reported sensation plus 7.5fr 00cc iab serial number (b)(4) but returned sensation plus 8fr 50cc iab serial number (b)(4).The returned product was evaluated.The iab was returned cut in two parts with the membrane completely unfolded and blood on the interior and exterior of the catheter.The extender tubing was also returned.One kink break was found on the catheter tubing and inner lumen approximately 0.3cm from the y-fitting.The optical fiber was found to be broken at this location.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and a leak was detected at the kinked location that penetrated the catheter tubing and inner lumen.The condition of the iab as received indicated a kink, optical fiber break and a catheter penetration confirming the reported problems.The penetration found in the catheter tubing and inner lumen appears to have been caused by a severe kink flexing back and forth that eventually penetrated the tubing and optical fiber causing the reported problems.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.Reference complaint #: (b)(4); record id: (b)(4).
 
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Brand Name
SENSATION PLUS 8FR. 50CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8011004
MDR Text Key125299644
Report Number2248146-2018-00617
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K122628
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 05/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/24/2022
Device Catalogue Number0684-00-0567
Device Lot Number3000088929
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2019
Device Age YR
Date Manufacturer Received05/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age46 YR
Patient Weight67
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