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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0470-01
Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/27/2020
Event Type  malfunction  
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.(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated a check iab catheter alarm.The customer was advised on several troubleshooting methods, but all were unsuccessful and pumping could not resume.A chest x-ray revealed the iab had migrated as well as a possible kink in the iab.It was decided to remove the iab, however, no physicians were available to do so at that time.Customer was advised to manually inflate/ deflate the iab until removal was possible.There was no patient harm or adverse event reported.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated a check iab catheter alarm.The customer was advised on several troubleshooting methods, but all were unsuccessful and pumping could not resume.A chest x-ray revealed the iab had migrated as well as a possible kink in the iab.It was decided to remove the iab, however, no physicians were available to do so at that time.Customer was advised to manually inflate/ deflate the iab until removal was possible.There was no patient harm or adverse event reported.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded with blood on the exterior of the catheter and between the catheter and the maquet sheath.A catheter tubing kink was observed at approximately 75.7cm from the iab tip.The returned device was inspected and found to have the tantalum markers in place per specification.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded.The evaluation confirmed the presence of the reported kink.However, the reported alarm and iab migration could not be confirmed since the iab pumped normally and cannot mimic the clinical settings or patient anatomy.We were unable to determine how or when the kink may have occurred.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. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key10852966
MDR Text Key216657814
Report Number2248146-2020-00611
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567106779
UDI-Public10607567106779
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
Report Date 12/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/12/2022
Device Model Number0684-00-0470-01
Device Catalogue Number0684-00-0434
Device Lot Number3000108622
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2020
Date Manufacturer Received12/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age57 YR
Patient Weight82
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