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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number UNKNOWN
Device Problems Leak/Splash (1354); Off-Label Use (1494)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2021
Event Type  malfunction  
Manufacturer Narrative
Complete event site name: (b)(6).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 during intra-aortic balloon (iab) therapy, the iab ruptured and blood back occurred.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The iab was removed and replaced with a new one.There was no patient harm or adverse event reported.
 
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.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) to (b)(6)was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).H3 other text : device not returned.
 
Event Description
N/a.
 
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Brand Name
UNKNOWN INTRA-AORTIC BALLOON
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
MDR Report Key12121999
MDR Text Key260078775
Report Number2248146-2021-00428
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/14/2021
Initial Date FDA Received07/06/2021
Supplement Dates Manufacturer Received10/12/2021
Supplement Dates FDA Received10/13/2021
Patient Sequence Number1
Treatment
UNKNOWN.; UNKNOWN.
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