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U.S. Department of Health and Human Services

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

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DATASCOPE FAIRFIELD MEGA 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0497
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 06/06/2017
Event Type  malfunction  
Manufacturer Narrative
Although good faith efforts have been attempted to retrieve the device, the device was not returned by the customer and so could not be evaluated. We are unable to confirm the reported event. If new information becomes available, a supplemental report will be submitted. (b)(4).
 
Event Description
The mega 8 fr. 50cc intra-aortic balloon's (iab) outer packaging was found wet upon delivery. The package was found in this manner prior to use. No patient involvement.
 
Manufacturer Narrative
(b)(4). No decontamination or visual inspection performed since product was not returned. A picture was provided which confirms the event of water damage, but we are unable to determine a root cause since he product was not returned and so could not be evaluated. 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 complaint could not be confirmed. Complaint # (b)(4).
 
Event Description
The mega 8 fr. 50cc intra-aortic balloon's (iab) outer packaging was found wet upon delivery. The package was found in this manner prior to use. No patient involvement.
 
Manufacturer Narrative
The mega catheter kit was returned intact and sealed. Visual examination was performed and no water damage was detected. The returned product was visually inspected and found to be within specification. An evaluation of the product was unable to duplicate the reported problem. The product performed according to specification. A device and lot history record review was completed for the reported product. No non-conformances were found that are considered to be related to the event. (b)(4).
 
Event Description
The mega 8 fr. 50cc intra-aortic balloon's (iab) outer packaging was found wet upon delivery. The package was found in this manner prior to use. No patient involvement.
 
Manufacturer Narrative
From: the mega catheter kit was returned intact and sealed. Visual examination was performed and no water damage was detected. The returned product was visually inspected and found to be within specification. An evaluation of the product was unable to duplicate the reported problem. The product performed according to specification. A device and lot history record review was completed for the reported product. No non-conformances were found that are considered to be related to the event. To: the mega catheter kit was returned intact and sealed. Visual examination was performed and no water damage was detected. The returned product was visually inspected and there were no defects observed. An evaluation of the product was unable to duplicate the reported problem. A device and lot history record review was completed for the reported product. No non-conformances were found that are considered to be related to the event. (b)(4).
 
Event Description
The mega 8 fr. 50cc intra-aortic balloon's (iab) outer packaging was found wet upon delivery. The package was found in this manner prior to use. No patient involvement.
 
Manufacturer Narrative
Correction: date received by manufacturer was inadvertently not entered in the follow up mdr #2 as 07/19/2017.
 
Event Description
The mega 8 fr. 50cc intra-aortic balloon's (iab) outer packaging was found wet upon delivery. The package was found in this manner prior to use. No patient involvement.
 
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 with the customer for its return. (b)(4).
 
Event Description
The mega 8 fr. 50cc intra-aortic balloon's (iab) outer packaging was found wet upon delivery. The package was found in this manner prior to use. No patient involvement.
 
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Brand NameMEGA 8FR. 50CC 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 Key6673627
MDR Text Key197021147
Report Number2248146-2017-00049
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K091449
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,Followup,Followup
Report Date 01/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/17/2020
Device Catalogue Number0684-00-0497
Device Lot Number3000045495
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received07/19/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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