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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0434
Device Problems Moisture Damage (1405); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 06/12/2017
Event Type  malfunction  
Manufacturer Narrative
Despite our good faith efforts, the product was not returned and so could not be evaluated. A lot history record review was completed for the reported product. No nonconformances were found that are considered to be related to the event. The complaint could not be confirmed. (b)(4).
 
Event Description
It was reported that 18 devices of this batch have fluid visible between the tray and tray cover with no sign of fluid contamination from the outside. The packaging is reported to be intact. This was reported by a distributor in (b)(4). This product was not shipped to the end user and therefore there was no patient involvement. This mdr is for 10 of 18 of the devices.
 
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. We continue our efforts to follow up for its return. (b)(4).
 
Event Description
It was reported that 18 devices of this batch have fluid visible between the tray and tray cover with no sign of fluid contamination from the outside. The packaging is reported to be intact. This was reported by a distributor in (b)(4). This product was not shipped to the end user and therefore there was no patient involvement. This mdr is for 10 of 18 of the devices.
 
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Brand NameSENSATION 7FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key6697829
MDR Text Key251389118
Report Number2248146-2017-00092
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeSA
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/04/2020
Device Catalogue Number0684-00-0434
Device Lot Number3000043013
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received09/26/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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