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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0497
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/13/2020
Event Type  malfunction  
Manufacturer Narrative
Additional initial reporter - (b)(6).Occupation - nurse.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 that during insertion of an intra-aortic balloon (iab), the balloon was unable to advance through the arterial sheath.There was no reported injury to the patient.
 
Event Description
It was reported that during insertion of an intra-aortic balloon (iab), the balloon was unable to advance through the arterial sheath.There was no reported injury to the patient.
 
Manufacturer Narrative
Additional information: section d - device available for eval? from: yes.To: no.The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Compliant #: (b)(4).H3 other text : device was discarded and not returned.
 
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Brand Name
MEGA 8FR. 50CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key10155089
MDR Text Key195420160
Report Number2248146-2020-00289
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K120868
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/05/2021
Device Catalogue Number0684-00-0497
Device Lot Number3000083935
Was Device Available for Evaluation? No
Date Manufacturer Received07/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age58 YR
Patient Weight73
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