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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0475
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/13/2020
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
It was reported, during the passage of the intra-aortic balloon(iab) the guide wire did not progress or at least came out, it was as if it was stuck and the doctor attributed it to a defect in the catheter.There was no reported injury to the patient.
 
Event Description
It was reported, during the passage of the intra-aortic balloon(iab) the guide wire did not progress or at least came out, it was as if it was stuck and the doctor attributed it to a defect in the catheter.There was no reported injury to the patient.
 
Manufacturer Narrative
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 # (b)(4).
 
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Brand Name
LINEAR 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 Key9977079
MDR Text Key188202545
Report Number2248146-2020-00228
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 06/25/2020
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 Expiration Date04/16/2022
Device Catalogue Number0684-00-0475
Device Lot Number3000094243
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 04/01/2020
Initial Date FDA Received04/20/2020
Supplement Dates Manufacturer Received06/24/2020
Supplement Dates FDA Received06/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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