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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0604
Device Problems Leak/Splash (1354); Difficult to Remove (1528)
Patient Problems Thrombus (2101); Injury (2348)
Event Date 06/29/2019
Event Type  Injury  
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.Complaint record id # (b)(4).
 
Event Description
After percutaneous cardiopulmonary support device (pcps), percutaneous coronary intervention (pci) was performed and intra-aortic balloon (iab) therapy started in a patient with acute myocardial infarction (ami).On the fifth day of balloon therapy, blood leakage was confirmed and the iab catheter was unable to be retrieved percutaneously from the patient although an attempt was made.Therefore, a surgical intervention was performed and it was entirely removed from the patient¿s body.Since thrombus appeared to adhere to the balloon of this iab catheter and observed in the patient¿s vessel as well, thrombus was percutaneously removed.The iabp therapy was discontinued.
 
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.Complaint # (b)(4).
 
Event Description
After percutaneous cardiopulmonary support device (pcps), percutaneous coronary intervention (pci) was performed and intra-aortic balloon (iab) therapy started in a patient with acute myocardial infarction (ami).On the fifth day of balloon therapy, blood leakage was confirmed and the iab catheter was unable to be retrieved percutaneously from the patient although an attempt was made.Therefore, a surgical intervention was performed and it was entirely removed from the patient¿s body.Since thrombus appeared to adhere to the balloon of this iab catheter and observed in the patient¿s vessel as well, thrombus was percutaneously removed.The iabp therapy was discontinued.
 
Event Description
After percutaneous cardiopulmonary support device (pcps), percutaneous coronary intervention (pci) was performed and intra-aortic balloon (iab) therapy started in a patient with acute myocardial infarction (ami).On the fifth day of balloon therapy, blood leakage was confirmed and the iab catheter was unable to be retrieved percutaneously from the patient although an attempt was made.Therefore, a surgical intervention was performed and it was entirely removed from the patient¿s body.Since thrombus appeared to adhere to the balloon of this iab catheter and observed in the patient¿s vessel as well, thrombus was percutaneously removed.The iabp therapy was discontinued.
 
Manufacturer Narrative
Changed from: product problem to: adverse event & product problem.Changed from: malfunction to: serious injury.The iab was returned with the sheath over the catheter tubing and blood on the exterior.The extender tubing was also returned.The membrane and inner lumen within the membrane was cut from the catheter and not returned.An underwater leak test of the catheter, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected.The reported events cannot be confirmed by the evaluation.We were unable to test the complete iab for the reported iab leak and difficulty removing the iab from the patient because of the returned condition of the catheter and we are unable to mimic the clinical setting.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.Complaint # (b)(4).
 
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Brand Name
TRANS-RAY PLUS 7.5 FR. 35CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8799634
MDR Text Key151344504
Report Number2248146-2019-00604
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
Report Date 09/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Catalogue Number0684-00-0604
Device Lot Number3000088979
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2019
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 06/29/2019
Initial Date FDA Received07/17/2019
Supplement Dates Manufacturer Received08/12/2019
09/05/2019
Supplement Dates FDA Received09/05/2019
09/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age65 YR
Patient Weight90
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