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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD LINEAR 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0475
Device Problems Moisture Damage (1405); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The iab insertion kit was returned unused sealed and intact. Fluid was found on the tray and pouch. The evaluation consisted of a visual inspection confirming the presence of fluid inside the device packaging. This fluid appearance is visually consistent with samples that have been tested via infrared spectrum analysis and found to be silicone. 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. A lot history record review was completed for the reported product. No nonconformances were found that are considered to be related to the event. (b)(4).
 
Event Description
It was reported by the customer there was moisture found inside of the intra-aortic balloon (iab) insertion kit. This was found prior to use on patient and therefore no patient involvement. The date of the event is unknown.
 
Manufacturer Narrative
The iab insertion kit was returned unused sealed and intact. Fluid was found on the tray and pouch. The evaluation consisted of a visual inspection confirming the presence of fluid inside the device packaging. A sample of the fluid has been tested via infrared spectrum analysis. The infra-red spectrophotometer 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. A lot history record review was completed for the reported product. No non-conformances were found that are considered to be related to the event. The reported event has been confirmed, there was no malfunction of the reported devices. Complaint # (b)(4).
 
Event Description
It was reported by the customer there was moisture found inside of the intra-aortic balloon (iab) insertion kit. This was found prior to use on patient and therefore no patient involvement. The date of the event is unknown.
 
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. (b)(4).
 
Event Description
It was reported by the customer there was moisture found inside of the intra-aortic balloon (iab) insertion kit. This was found prior to use on patient and therefore no patient involvement. The date of the event is unknown.
 
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Brand NameLINEAR 7.5 FR. 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 Key6905995
MDR Text Key250906970
Report Number2248146-2017-00426
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0684-00-0475
Device Lot Number3000051291
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received12/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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