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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 IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0605
Device Problems Difficult to Insert (1316); Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/16/2020
Event Type  malfunction  
Manufacturer Narrative
Event site postal code: (b)(6).Event site state: (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.Complaint # (b)(4).
 
Event Description
It was reported that during the insertion of an intra-aortic balloon (iab), the sheath was observed damaged and the catheter was unable to be inserted through the sheath.The iab was replaced and therapy was provided.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.(b)(4).
 
Event Description
It was reported that during the insertion of an intra-aortic balloon (iab), the sheath was observed damaged and the catheter was unable to be inserted through the sheath.The iab was replaced and therapy was provided.There was no reported injury to the patient.
 
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Brand Name
TRANS-RAY PLUS 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 Key10379101
MDR Text Key202198348
Report Number2248146-2020-00406
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 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/06/2023
Device Catalogue Number0684-00-0605
Device Lot Number3000111817
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received08/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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