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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD LINEAR 7.5 FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0474
Device Problems Device Alarm System (1012); Difficult to Remove (1528)
Patient Problem No Code Available (3191)
Event Date 02/07/2018
Event Type  Death  
Manufacturer Narrative
Additional information: contact at event site reported to distributor, (b)(6). Complete facility name reported as: (b)(6). 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
The patient presented with acute cardiogenic shock and was admitted to the hospital. After emergency percutaneous coronary intervention (pci), their hemodynamic state was unstable and their blood pressure was low. After initiation of intra-aortic (iab) balloon therapy, the patient was reported to be normal. It was reported that after approximately two days of iab therapy, there was blood found in the iab catheter tubing, but the pump did not alarm. Therapy was terminated. There was reported difficulty removing the iab catheter from the patient and surgical removal was required.
 
Manufacturer Narrative
Correction: outcomes of adverse event: selected 'death' and added date of death (b)(6) 2018. Describe event or problem added statement 'the patient expired on (b)(6) 2018, but the death was not attributed to the device'. Type of reportable event: selected death. (b)(4).
 
Event Description
The patient presented with acute cardiogenic shock and was admitted to the hospital. After emergency percutaneous coronary intervention (pci), their hemodynamic state was unstable and their blood pressure was low. After initiation of intra-aortic (iab) balloon therapy, the patient was reported to be normal. It was reported that after approximately two days of iab therapy, there was blood found in the iab catheter tubing, but the pump did not alarm. Therapy was terminated. There was reported difficulty removing the iab catheter from the patient and surgical removal was required. The patient expired on (b)(6) 2018, but the death was not attributed to the device.
 
Manufacturer Narrative
Device evaluation: 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. A visual examination of the product detected the inner lumen within the membrane was completely separated within a kink approximately 20. 6cm from iab tip and the tip of the inner lumen was out of place inside the membrane. An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and another leak was detected on the membrane approximately 4. 3cm from the rear seal measuring 4. 1cm in length. The evaluation confirms the reported leak, blood in tubing & difficult/unable to remove iab from patient problems. The break found in the inner lumen appears to have been the result of a severe kink, which eventually failed and allowed blood to leak into the membrane and catheter tubing causing the reported blood in tubing and difficult/unable to remove iab from patient problems. We are unable to determine when this may have occurred. 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.
 
Event Description
The patient presented with acute cardiogenic shock and was admitted to the hospital. After emergency percutaneous coronary intervention (pci), their hemodynamic state was unstable and their blood pressure was low. After initiation of intra-aortic (iab) balloon therapy, the patient was reported to be normal. It was reported that after approximately two days of iab therapy, there was blood found in the iab catheter tubing, but the pump did not alarm. Therapy was terminated. There was reported difficulty removing the iab catheter from the patient and surgical removal was required.
 
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Brand NameLINEAR 7.5 FR. 34CC 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 Key7313509
MDR Text Key101507274
Report Number2248146-2018-00142
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2020
Device Catalogue Number0684-00-0474
Device Lot Number3000055094
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received03/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2017
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: 03/05/2018 Patient Sequence Number: 1
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