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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 06/25/2019
Event Type  malfunction  
Manufacturer Narrative
(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. (b)(4).
 
Event Description
It was reported that during insertion of the intra-aortic balloon (iab), the balloon was unable to be advanced into the patient. The iab was replaced. There was no reported injury to the patient.
 
Manufacturer Narrative
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. Reference complaint # (b)(4).
 
Event Description
It was reported that during insertion of the intra-aortic balloon (iab), the balloon was unable to be advanced into the patient. The iab was replaced. There was no reported injury to the patient.
 
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Brand NameLINEAR 7.5 FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8798071
MDR Text Key151306172
Report Number2248146-2019-00599
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,Followup
Report Date 09/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2021
Device Catalogue Number0684-00-0475
Device Lot Number3000084494
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2019
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received09/11/2019
Is This a Reprocessed and Reused Single-Use Device? No

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