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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. 35CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0604
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/07/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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
Used on april 7, 2020. Although the sheath was used for insertion through a sheath, the sheath was poorly cut and could not be inserted properly. In the end, he was able to open 35mm of the same size and insert it safely. Additional information for this case has been obtained. When the insertion sheath and dilator assembly was attempted to be inserted in the puncture site, the dilator got stuck and was unable to be advanced within the subcutaneous tissue. The insertion sheath was replaced to the a non-maquet sheath (medikit super sheath). Although the iab catheter was inserted into the replacement non-maquet sheath, there was severe resistance felt and could not be advanced anymore. Another same size iab catheter was used instead to continue iabp therapy. There were no adverse consequences to the patient reported.
 
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Brand NameTRANS-RAY PLUS 7.5 FR. 35CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
dorota wolpiuk
15 law drive
fairfield, NJ 07004
MDR Report Key9944140
MDR Text Key187568966
Report Number2248146-2020-00215
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/12/2022
Device Catalogue Number0684-00-0604
Device Lot Number3000104726
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received04/23/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/12/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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