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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH UNKNOWN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH UNKNOWN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Failure to Read Input Signal (1581)
Patient Problem No Code Available (3191)
Event Date 11/22/2018
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was unable to be reviewed as we were not able to obtain the serial number for the iabp associated with this complaint. The customer has not alleged a malfunction of the iabp. However, additional information has been requested and a supplemental report will be submitted in the event that new information is provided. (b)(6).
 
Event Description
It was reported that during the insertion of the intra-aortic balloon pump (iab) catheter on the patient using x-ray, it was not possible to detect the distal radiopaque marker. The patient was transferred to the coronary angiography room. The signal of the marker was split. The medical staff decided to remove the iab catheter. During the removal, a part of the device would not go down. Therefore, the femoral artery was opened to remove the iab catheter. The removed iab appeared to be intact. The iab catheter was removed before the intra-aortic balloon pump (iabp) therapy was started. Therefore, there was no reported malfunction of the involved iabp. The model & serial number of the pump was not reported. The related iab complaint was submitted under mgf report# 2248146-2019-00012.
 
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Brand NameUNKNOWN
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key8233491
MDR Text Key132604290
Report Number2249723-2019-00058
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received12/18/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/10/2019 Patient Sequence Number: 1
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