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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0475
Device Problems Restricted Flow rate (1248); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/01/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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 console generated a catheter restriction alarm.Soon after the alarm, blood was seen in the helium tubing.The catheter was then removed from the patient.The physician who performed the iab insertion claims to have encountered tortuosity while inserting the catheter.There was no reported injury to the patient.
 
Manufacturer Narrative
Updated sections: b4, g4, g7, h2, h3, h6, h10.The product was returned with the membrane completely unfolded and blood was observed on the interior and exterior of the catheter.The extracorporeal, extender and pressure tubing were also returned.Two kinks were observed on the catheter tubing at 70.4 cm and 76.5 cm from the iab tip.In underwater leak test of the balloon, catheter, inner lumen, y-fitting, extracorporeal, extender and pressure tubing was performed and one leak was detected on the membrane approximately 1.28 cm from the rear seal measuring 0.19 cm in length.The technician then attempted to insert a laboratory 0.025¿ guide wire through the inner lumen of the returned iab and found slight traces of blood.The inner lumen was able to be cleared.The reported problem was most likely triggered by a leak which was found on the membrane.The penetration found in the membrane appears to have been caused by a sharp object.We are unable to determine when the penetration 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.Complaint record # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated a catheter restriction alarm.Soon after the alarm, blood was seen in the helium tubing.The catheter was then removed from the patient.The physician who performed the iab insertion claims to have encountered tortuosity while inserting the catheter.There was no reported injury to the patient.
 
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Brand Name
LINEAR 7.5 FR. 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key9717579
MDR Text Key187570277
Report Number2248146-2020-00098
Device Sequence Number1
Product Code DSP
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,health
Type of Report Initial,Followup
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/03/2022
Device Catalogue Number0684-00-0475
Device Lot Number3000105530
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2020
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 02/01/2020
Initial Date FDA Received02/17/2020
Supplement Dates Manufacturer Received03/03/2020
Supplement Dates FDA Received03/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age91 YR
Patient Weight77
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