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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC IAB; 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 10/24/2019
Event Type  malfunction  
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.(b)(4).
 
Event Description
It was reported during intra-aortic balloon (iab) therapy, resistance was felt trying to advance the balloon over the guide wire into the patient.The balloon was replaced.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 record # (b)(4).
 
Event Description
It was reported during intra-aortic balloon (iab) therapy, resistance was felt trying to advance the balloon over the guide wire into the patient.The balloon was replaced.There was no reported injury to the patient.
 
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Brand Name
LINEAR 7.5 FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key9335917
MDR Text Key192021280
Report Number2248146-2019-00879
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,foreig
Type of Report Initial,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/28/2022
Device Catalogue Number0684-00-0475
Device Lot Number3000093376
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Manufacturer Received12/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age45 YR
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