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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY 7FR. 34CC IAB - JAPAN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD TRANS-RAY 7FR. 34CC IAB - JAPAN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0513
Device Problems Kinked (1339); Material Rupture (1546)
Patient Problem Calcium Deposits/Calcification (1758)
Event Date 11/28/2017
Event Type  malfunction  
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 during intra-aortic balloon (iab) procedure on an unstable angina pectoris patient, a balloon rupture was noted.When the iab pump restarted for withdrawal cardiopulmonary bypass, the internal pressure on the balloon appeared that waveform could have resulted from a kink and blood back run was found on the extension tube.Mild sclerosis, tortuosity and aortic calcification were noted in the patient vessel.Replaced iab to continue therapy.No patient injury was reported.
 
Manufacturer Narrative
Initial reporter-changed to dr.(b)(6).The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.The returned sheath was over the catheter.The extender tubing was also returned.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and one leak was detected on the membrane approximately 19.3cm from the rear seal measuring 0.10cm in length.The optical fiber was found to be broken within the catheter tubing 47.5cm from the iab tip.The evaluation confirmed the reported leak, blood in tubing & difficult/unable to monitor balloon waveform problem.The reported blood in tubing problem was most likely triggered by a leak which was found on the membrane.The penetration found appears to have been caused by a sharp object.It is difficult to determine how or when the penetration occurred.The optical fiber was found to be broken, confirming the reported difficult/unable to monitor balloon waveform problem.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.Complaint # (b)(4), record # (b)(4).
 
Event Description
It was reported that on (b)(6) 2017 during intra-aortic balloon (iab) procedure on an unstable angina pectoris patient, a balloon rupture was noted.When the iab pump restarted for withdrawal cardiopulmonary bypass, the internal pressure on the balloon appeared that waveform could have resulted from a kink and blood back run was found on the extension tube.Mild sclerosis, tortuosity and aortic calcification were noted in the patient vessel.Replaced iab to continue therapy.No patient injury was reported.
 
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Brand Name
TRANS-RAY 7FR. 34CC IAB - JAPAN
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 Key7148700
MDR Text Key96027421
Report Number2248146-2017-00743
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
Report Date 01/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/03/2020
Device Catalogue Number0684-00-0513
Device Lot Number3000043012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2017
Is the Reporter a Health Professional? Yes
Device AgeYR
Date Manufacturer Received01/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/03/2017
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 Age72 YR
Patient Weight55
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