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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0434
Device Problem Failure to Advance (2524)
Patient Problems Calcium Deposits/Calcification (1758); Hypoxia (1918); Myocardial Infarction (1969); Cardiogenic Shock (2262)
Event Date 12/08/2017
Event Type  malfunction  
Manufacturer Narrative
The iab was returned with the membrane completely unfolded. No blood was visible on the catheter. The extender tubing was also returned. The sheath was not returned for evaluation. Two kinks were found on the catheter tubing near the y-fitting approximately 74. 4cm and 76. 2cm from the iab tip. 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, extracorporeal and extender tubing was performed and no leaks were detected. A leak may impact the ability to maintain vacuum. 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. An evaluation of the product was unable to duplicate the reported problem. The product performed according to specification. 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 during intra-aortic balloon (iab) insertion, the iab would not advance or pass through the sheath. The indication for use was due to patient being admitted due to acute myocardial infarction with elevation of the st segment in the inferior wall with electrical extension to the right ventricle without success criteria for thrombolysis, for which rescue angioplasty was performed. It went from an emergency to a cardiac catheterization with evidence of severe multivessel coronary disease and extensive calcifications, with a critical lesion in the proximal third and middle of the right coronary artery with a high thrombotic load; mechanical recanalization, angioplasty and stent implantation were performed, a non-surgical approach. Due to severe reflux with intracoronary, adenosine was required. Cardiogenic shock with hypoxemia then occurred, for which orotracheal intubation was performed and required mechanical support with iab. The iab would not advance, the iab was checked and verified to be adequate, however due to the instability of the patient the iab was replaced. The replacement iab was inserted successfully and therapy started without complications. There was no reported injury to the patient.
 
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 during intra-aortic balloon (iab) insertion, the iab would not advance or pass through the sheath. The indication for use was due to patient being admitted due to acute myocardial infarction with elevation of the st segment in the inferior wall with electrical extension to the right ventricle without success criteria for thrombolysis, for which rescue angioplasty was performed. It went from an emergency to a cardiac catheterization with evidence of severe multivessel coronary disease and extensive calcifications, with a critical lesion in the proximal third and middle of the right coronary artery with a high thrombotic load; mechanical recanalization, angioplasty and stent implantation were performed, a non-surgical approach. Due to severe reflux with intracoronary, adenosine was required. Cardiogenic shock with hypoxemia then occurred, for which orotracheal intubation was performed and required mechanical support with iab. The iab would not advance, the iab was checked and verified to be adequate, however due to the instability of the patient the iab was replaced. The replacement iab was inserted successfully and therapy started without complications. There was no reported injury to the patient.
 
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Brand NameSENSATION 7FR. 40CC 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 Key7188711
MDR Text Key115810797
Report Number2248146-2018-00020
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/03/2020
Device Catalogue Number0684-00-0434
Device Lot Number3000048410
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received06/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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