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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0605
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2020
Event Type  malfunction  
Manufacturer Narrative
Event site postal code: (b)(6).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.Complaint record id # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, it was noticed that there was a deformation on the tip of the sheath.Another manufacturer's iab was used instead and therapy was continued successfully.There was no reported injury to the patient.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, it was noticed that there was a deformation on the tip of the sheath.Another manufacturer's iab was used instead and therapy was continued successfully.There was no reported injury to the patient.
 
Manufacturer Narrative
The 7.5 fr maquet sheath was returned with the dilator and the original 0.025¿ guidewire.No signs of blood or clinical use were observed.No kinks or physical defects were found.An insertion test was performed with the sheath and dilator.The sheath opening was observed to slightly agape and bigger than the dilator circumference.A laboratory pin gage was used to measure the sheath opening and was observed to be 0.277 cm.According to the specifications, the sheath opening was confirmed to be damaged.The evaluation confirms the reported damaged sheath.We are unable to determine how this 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.Complaint # (b)(4).
 
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Brand Name
TRANS-RAY PLUS 7.5 FR. 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key10254856
MDR Text Key198549582
Report Number2248146-2020-00321
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,foreig
Type of Report Initial,Followup
Report Date 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/03/2021
Device Catalogue Number0684-00-0605
Device Lot Number3000076716
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2020
Date Manufacturer Received08/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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