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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD YAMATO PLUS-R 7.5FR. 35CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD YAMATO PLUS-R 7.5FR. 35CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0549-02
Device Problem Insufficient Information (3190)
Patient Problem Swelling (2091)
Event Date 06/17/2016
Event Type  malfunction  
Manufacturer Narrative
Correction: date rec'd by mfr was not entered in the initial mdr. Date rec'd by mfr: 06/20/2016.
 
Event Description
The iab catheter was inserted in the patient and iabp therapy started. The catheter was inserted from the right femoral artery and during therapy it was noted that the site it was inserted from became swollen. The catheter was removed and another iab catheter was inserted in the left femoral artery and therapy continued.
 
Manufacturer Narrative
The device has not been returned to the manufacturer and we're unable to complete an evaluation on the affected product. When its' provided we will send a supplemental report with our additional findings. We continue in our efforts to follow up with the customer for its' return. (b)(4).
 
Event Description
The iab catheter was inserted in the patient and iabp therapy started. The catheter was inserted from the right femoral artery and during therapy it was noted that the site it was inserted from became swollen. The catheter was removed and another iab catheter was inserted in the left femoral artery and therapy continued.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and traces of blood on the exterior of the catheter. No blood was observed inside the catheter. No kinks were found. The technician was able to successfully aspirate/flush the inner lumen. The technician was able to insert a laboratory 0. 025¿ guide wire through the inner lumen of the iab returned without difficulty. No obstructions were felt. An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected. The evaluation of the returned iab included functional tests and visual inspections. No abnormalities were found. (b)(4).
 
Event Description
The iab catheter was inserted in the patient and iabp therapy started. The catheter was inserted from the right femoral artery and during therapy it was noted that the site it was inserted from became swollen. The catheter was removed and another iab catheter was inserted in the left femoral artery and therapy continued.
 
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Brand NameYAMATO PLUS-R 7.5FR. 35CC IAB
Type of DeviceSYSTEM, 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 Key5761299
MDR Text Key273193715
Report Number2248146-2016-00053
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/12/2018
Device Catalogue Number0684-00-0549-02
Device Lot Number3000011693
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received06/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/30/2016 Patient Sequence Number: 1
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