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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 - JAPAN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD YAMATO PLUS-R 7.5FR. 35CC IAB - JAPAN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0549-02
Device Problems Material Rupture (1546); Device Displays Incorrect Message (2591)
Patient Problems Arteriosclerosis (1722); Calcium Deposits/Calcification (1758); No Code Available (3191)
Event Date 10/30/2017
Event Type  malfunction  
Manufacturer Narrative
Correction: the device was returned as of 12/13/2017 and should have been included on the initial mdr submission. The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath. The returned sheath was over the catheter. An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and one leak was detected on the membrane approximately 2. 0cm from the rear seal measuring 0. 02cm in length. The reported alarm, check iab catheter & blood in tubing was most likely triggered by a leak which was found on the membrane. Under magnification, a whitish patch was observed around the leak. This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta. 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 intra-aortic balloon (iab) therapy was started on (b)(6) 2017 on an unstable angina pectoris patient. On (b)(6) 2017 at 1pm a ¿check iab catheter¿ alarm was generated by the pump. At 6am the same alarm ¿check iab catheter¿ was generated again and blood was found in the catheter. The customer suspected balloon rupture; iab was removed and iab therapy was discontinued. No patient injury was reported. Severe sclerosis and calcification in the artery, and mild tortuosity were noted in the patient vessel.
 
Manufacturer Narrative
Complaint # (b)(4).
 
Event Description
It was reported that intra-aortic balloon (iab) therapy was started on (b)(6) 2017 on an unstable angina pectoris patient. On (b)(6) 2017 at 1pm a ¿check iab catheter¿ alarm was generated by the pump. At 6am the same alarm ¿check iab catheter¿ was generated again and blood was found in the catheter. The customer suspected balloon rupture; iab was removed and iab therapy was discontinued. No patient injury was reported. Severe sclerosis and calcification in the artery, and mild tortuosity were noted in the patient vessel.
 
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. (b)(4).
 
Event Description
It was reported that intra-aortic balloon (iab) therapy was started on (b)(6) 2017 on an unstable angina pectoris patient. On (b)(6) 2017 at 1pm a ¿check iab catheter¿ alarm was generated by the pump. At 6am the same alarm ¿check iab catheter¿ was generated again and blood was found in the catheter. The customer suspected balloon rupture; iab was removed and iab therapy was discontinued. No patient injury was reported. Severe sclerosis and calcification in the artery, and mild tortuosity were noted in the patient vessel.
 
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Brand NameYAMATO PLUS-R 7.5FR. 35CC IAB - JAPAN
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 Key7124602
MDR Text Key249627720
Report Number2248146-2017-00720
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 02/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/22/2019
Device Catalogue Number0684-00-0549-02
Device Lot Number3000036894
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received02/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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