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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 Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter occupation: bsn, rn, director of cardiovascular services/administrator/supervisor.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 record id # (b)(4).
 
Event Description
It was reported that the customer noticed a liquid-type condensation on their intra-aortic balloon (iab).Upon inspection, it was reported that seven other iabs were affected with the same issue.There was no patient involvement and no adverse event was reported.This report is for the seventh of eight iabs.Separate reports will be submitted for each of the other seven iabs.
 
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).
 
Event Description
It was reported that the customer noticed a liquid-type condensation on their intra-aortic balloon (iab).Upon inspection, it was reported that seven other iabs were affected with the same issue.There was no patient involvement and no adverse event was reported.This report is for the seventh of eight iabs.Separate reports will be submitted for each of the other seven iabs.
 
Manufacturer Narrative
An evaluation was performed of the returned product.It has not been exposed to any clinical or known biohazardous conditions.The catheter kit and insertion kit were returned intact and sealed.The evaluation consisted of a visual inspection confirming the presence of a clear fluid inside the kits.An iab remove from retainers test was performed on the device and recorded the peak force that was required to remove the iab from the retainer, as indicated on the gage.The device was reported to contain a liquid type condensation inside the packaging.Infra-red spectrophotometer results confirmed that the substance was silicone which had migrated from inside of the packaging during shipping/storage.Silicone is used as a lubricant during the manufacturing process and has been determined to be biocompatible.Devices with silicone found in the packaging can continue to be used and pose no risk to the patient per iab product specification.This silicone is not foreign matter and is not a nonconformity of the device.The reported event for silicone migration is confirmed.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period (b)(6) 2019 through (b)(6) 2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.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
MDR Report Key11766514
MDR Text Key248883708
Report Number2248146-2021-00281
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,Followup
Report Date 09/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/18/2022
Device Model Number0684-00-0470-01
Device Catalogue Number0684-00-0434
Device Lot Number3000104733
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2021
Date Manufacturer Received09/16/2021
Patient Sequence Number1
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