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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD YAMATO PLUS-R 7.5FR. 30CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD YAMATO PLUS-R 7.5FR. 30CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0549-01
Device Problems Filling Problem (1233); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/17/2019
Event Type  malfunction  
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.Complaint record id # (b)(4).
 
Event Description
It was reported during intra-aortic balloon(iab) therapy, an automatic filling error occurred.The pumping was stopped.The customer visually confirmed, sand-like foreign matter in the gas tube.Therefore, it was determined there was a balloon leak.Since the patient has been in stable condition, the balloon catheter was removed safely from the patient and intra-aortic balloon pump(iabp) therapy was completed with no issues.There was no reported injury to the patient.
 
Event Description
It was reported during intra-aortic balloon(iab) therapy, an automatic filling error occurred.The pumping was stopped.The customer visually confirmed, sand-like foreign matter in the gas tube.Therefore, it was determined there was a balloon leak.Since the patient has been in stable condition, the balloon catheter was removed safely from the patient and intra-aortic balloon pump(iabp) therapy was completed with no issues.There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the competitor sheath, extender tubing, extracorporeal tubing, pressure tubing, and one way valve.Blood is observed in the interior and on the exterior of the catheter.Moderate blood was observed in between the catheter and the sheath.Three kinks were observed and were located on the catheter tubing at approximately 33.8cm, 34.3cm, and 71.4 cm from the iab tip.No other defects were observed.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and pressure tubing was performed and the leak was found on the catheter tubing at approximately 31.5 cm from the iab tip.A technician found no obstruction in the inner lumen, the inner lumen leak test was performed and no leaks were observed.The penetration found in the catheter tubing appears to have been caused by a sharp object.Though we are unable to determine when the penetration may have occurred, it is likely that it caused the reported problem.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 during intra-aortic balloon(iab) therapy, an automatic filling error occurred.The pumping was stopped.The customer visually confirmed, sand-like foreign matter in the gas tube.Therefore, it was determined there was a balloon leak.Since the patient has been in stable condition, the balloon catheter was removed safely from the patient and intra-aortic balloon pump(iabp) therapy was completed with no issues.There was no reported injury to the patient.
 
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.Complaint record #(b)(4).
 
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Brand Name
YAMATO PLUS-R 7.5FR. 30CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key9554734
MDR Text Key188657477
Report Number2248146-2020-00009
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
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 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/10/2022
Device Catalogue Number0684-00-0549-01
Device Lot Number3000094235
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2020
Was the Report Sent to FDA? Yes
Date Manufacturer Received01/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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