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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0480-01
Device Problems Off-Label Use (1494); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2021
Event Type  malfunction  
Manufacturer Narrative
Event site postal code: (b)(6).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.Complaint record id #: (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the iab was attached the patient's chest leaving a "c"-shaped loop in the iab which bends and kinks and blocks a lot of patient movement.The insertion was reported to be axillary, which is not the method described in the device instructions for use.This is the fourth iab the customer has had this issue with during this event.There was no patient harm or adverse event reported.This report is for the fourth iab used in this event.Separate reports will be sent for first, second, and third iabs used.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter and between the catheter and the sheath.Three kinks were found on the catheter tubing approximately 51.1cm, 71.4cm and 76.5cm from the iab tip.The inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.The evaluation confirmed the kinks in the catheter.However it was reported that the catheter was inserted axillary.Axillary is off label use and is not recommended per the instructions for use.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 over past three (3) months).However a capa request is opened for the reported failure mode.Reference complaint (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the iab was attached the patient's chest leaving a "c"-shaped loop in the iab which bends and kinks and blocks a lot of patient movement.The insertion was reported to be axillary, which is not the method described in the device instructions for use.This is the fourth iab the customer has had this issue with during this event.There was no patient harm or adverse event reported.This report is for the fourth iab used in this event.Separate reports will be sent for first, second, and third iabs used.
 
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Brand Name
LINEAR 7.5 FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key11366493
MDR Text Key233116106
Report Number2248146-2021-00116
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567106564
UDI-Public10607567106564
Combination Product (y/n)N
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2023
Device Model Number0684-00-0480-01
Device Catalogue Number0684-00-0475
Device Lot Number3000114160
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2021
Date Manufacturer Received03/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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