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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0296-01
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/22/2020
Event Type  malfunction  
Manufacturer Narrative
Event site postal code: (b)(6).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).Device not returned.
 
Event Description
It was reported that during insertion of the intra-aortic balloon (iab), the customer felt resistance and was unable to advance the guide wire.The iab was replaced with a new one, however, the same issue occurred.A third iab was placed successfully.There was no patient harm or adverse event reported.This report is for the first iab used in this event.A separate report will be submitted for the second iab used.
 
Event Description
It was reported that during insertion of the intra-aortic balloon (iab), the customer felt resistance and was unable to advance the guide wire.The iab was replaced with a new one, however, the same issue occurred.A third iab was placed successfully.There was no patient harm or adverse event reported.This report is for the first iab used in this event.A separate report will be submitted for the second iab used.
 
Manufacturer Narrative
Additional information: section d added serial # (b)(6).Device evaluation: the product was returned with the membrane completely unfolded with traces of blood on the exterior of the catheter.The one-way valve was also returned and attached to the extracorporeal tubing.The catheter tubing was observed to be flattened along its length.This may occur if a vacuum is held with the one-way valve for an extended period of time, causing the catheter tubing to lose its round shape.A bent on the inner lumen was also observed near the y-fitting at approximately 74.2cm from the iab tip.The one-way valve was vacuum test and it held vacuum the technician attempted to insert the returned 0.025¿ guidewire through the inner lumen and was able to insert the guidewire but with difficulty.Obstruction felt at the bent section of the inner lumen.The evaluation confirms the reported problem.A bent along the length of the inner lumen could cause difficulty advancing the guidewire.However, we are unable to determine how or when this may have occurred.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints reference complaint #(b)(4).
 
Event Description
It was reported that during insertion of the intra-aortic balloon (iab), the customer felt resistance and was unable to advance the guide wire.The iab was replaced with a new one, however, the same issue occurred.A third iab was placed successfully.There was no patient harm or adverse event reported.This report is for the first iab used in this event.A separate report will be submitted for the second iab used.
 
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.Reference complaint # (b)(4).
 
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Brand Name
MEGA 8FR. 50CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key11154268
MDR Text Key226301502
Report Number2248146-2021-00016
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108001
UDI-Public10607567108001
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,foreig
Type of Report Initial,Followup,Followup
Report Date 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/05/2023
Device Model Number0684-00-0296-01
Device Catalogue Number0684-00-0497
Device Lot Number3000114163
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2021
Date Manufacturer Received02/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age68 YR
Patient Weight71
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