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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); Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Date 07/21/2017
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.We continue our efforts to follow up for its return.(b)(4).
 
Event Description
It was reported that 21 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 6 of 21 of the devices.
 
Manufacturer Narrative
A visual inspection confirmed the presence of fluid inside the packaging of the returned device.It was suspected that the fluid was silicone.Devices were sampled and sent for infra-red spectrophotometer (ir) testing.The results confirmed that the substance was silicone which had migrated inside the packaging of the device during storage.Silicone is used as a lubricant during the manufacturing process and has been determined to be biocompatible.Devices with silicone found in the packaging can continue to be used and pose no risk to the patient.The event has been confirmed, there was no malfunction of the reported devices.(b)(4).
 
Event Description
It was reported that 21 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 6 of 21 of the devices.
 
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Brand Name
SENSATION 7FR. 40CC IAB
Type of Device
SYSTEM, 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 Key6778030
MDR Text Key82473016
Report Number2248146-2017-00230
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 Other
Type of Report Initial,Followup
Report Date 10/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date04/03/2020
Device Catalogue Number0684-00-0434
Device Lot Number3000048410
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2017
Is the Reporter a Health Professional? No
Device AgeYR
Date Manufacturer Received09/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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