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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 Leak/Splash (1354); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/16/2019
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) sheathless insertion in an acute myocardial infarction (ami) patient, the iab catheter was unable to advance.The customer found a rupture on the balloon membrane after the attempt to insert the iab catheter.The iab was replaced to continue therapy.There was no reported injury to the patient.
 
Event Description
It was reported that during intra-aortic balloon (iab) sheathless insertion in an acute myocardial infarction (ami) patient, the iab catheter was unable to advance.The customer found a rupture on the balloon membrane after the attempt to insert the iab catheter.The iab was replaced to continue therapy.There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane loosely folded and traces of blood found on the exterior of the catheter with the one-way valve attached.No blood was observed inside the iab catheter.A laboratory insertion test was unable to be performed due to the membrane being unfurled.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.The returned condition of the product indicates that the reported leak, blood in tubing problem resulted from a condition known as ¿channeling¿.Arterial blood under pressure may run the length of the folds in the balloon membrane and drip or be expelled under arterial pressure from the balloon/catheter junction.This "channeling" is not a leak and will diminish as the iab catheter is inserted.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 (b)(4).
 
Manufacturer Narrative
Additional information - serial # (b)(4).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 # (b)(4), record id # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) sheathless insertion in an acute myocardial infarction (ami) patient, the iab catheter was unable to advance.The customer found a rupture on the balloon membrane after the attempt to insert the iab catheter.The iab was replaced to continue therapy.There was no reported injury to the patient.
 
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.Reference complaint #ca-cpl-2019-01100; record id (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) sheathless insertion in an acute myocardial infarction (ami) patient, the iab catheter was unable to advance.The customer found a rupture on the balloon membrane after the attempt to insert the iab catheter.The iab was replaced to continue therapy.There was no reported injury to the patient.
 
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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 Key8583687
MDR Text Key144712426
Report Number2248146-2019-00407
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,Followup
Report Date 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/07/2021
Device Catalogue Number0684-00-0549-01
Device Lot Number3000072337
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2019
Date Manufacturer Received07/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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