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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD YAMATO PLUS-R 7.5FR. 30CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE 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 Bent (1059); Kinked (1339)
Patient Problems Calcium Deposits/Calcification (1758); Death (1802); Hemorrhage/Bleeding (1888); Rupture (2208); Cardiac Tamponade (2226)
Event Date 12/16/2017
Event Type  Death  
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.(b)(4).
 
Event Description
It was reported that on (b)(6) 2017 intra-aortic balloon (iab) therapy started on an ami patient.The sheath was difficult to advance.While attempts were made to insert the iab, the guide wire bent, and the sheath was being kinked.The iab was unable to be removed and bleeding would not stop.An incision was made to remove iab.Ended therapy on (b)(6) 2017.On (b)(6) 2017, the patient expired by cardiac tamponade due to myocardial rupture.Mild tortuosity, sclerosis and calcification were noted in the patient vessel.
 
Manufacturer Narrative
Additional information - following statement was missing from previous supplemental report submission: 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
It was reported that on (b)(6) 2017 intra-aortic balloon (iab) therapy started on an ami patient.The sheath was difficult to advance.While attempts were made to insert the iab, the guide wire bent, and the sheath was being kinked.The iab was unable to be removed and bleeding would not stop.An incision was made to remove iab.Ended therapy on (b)(6) 2017.On (b)(6) 2017, the patient expired by cardiac tamponade due to myocardial rupture.Mild tortuosity, sclerosis and calcification were noted in the patient vessel.
 
Manufacturer Narrative
The iab was returned unused with the membrane folded inside the t-handle.No blood was visible on the catheter.The insertion components were also returned.The sheath was not returned for evaluation.The 0.035¿ returned guide wire was found to be near the middle.The one-way valve was vacuum tested and it held vacuum.A laboratory insertion test was performed using a 7.5fr laboratory sheath since the sheath was not returned for evaluation.The technician was able to successfully insert the balloon through the sheath.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.The evaluation confirms the reported bent guide wire.We are unable to determine how this occurred.We are unable to confirm the reported difficult/unable to remove iab from patient and difficulty during insertion because we are unable to mimic the clinical setting and the sheath not returned.Complaint # (b)(4), record # (b)(4).
 
Event Description
It was reported that on (b)(6) 2017 intra-aortic balloon (iab) therapy started on an ami patient.The sheath was difficult to advance.While attempts were made to insert the iab, the guide wire bent, and the sheath was being kinked.The iab was unable to be removed and bleeding would not stop.An incision was made to remove iab.Ended therapy on (b)(6 2017.On (b)(6) 2017, the patient expired by cardiac tamponade due to myocardial rupture.Mild tortuosity, sclerosis and calcification were noted in the patient vessel.
 
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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 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 Key7198850
MDR Text Key97483655
Report Number2248146-2018-00026
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,distri
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 02/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/01/2020
Device Catalogue Number0684-00-0549-01
Device Lot Number3000053158
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2018
Is the Reporter a Health Professional? Yes
Device AgeYR
Date Manufacturer Received02/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age83 YR
Patient Weight62
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