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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 Material Rupture (1546)
Patient Problem No Code Available (3191)
Event Date 01/05/2018
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not reviewed per company standard operating procedure since the device serial number was not provided. This report has been sent per company protocol of co-reporting when the event description entails a serious injury or death regarding the iabp/ iab. There was no further information provided. (b)(6). Additional information has been requested, and a supplemental report will be sent upon receipt.
 
Event Description
It was reported that the intra-aortic balloon (iab) ruptured. The nurse called the physician and the advanced licensed practitioner assessed the event to report blood marching up the catheter towards the pump. The intra-aortic balloon pump (iabp) then stopped inflating. Furthermore, the catheter was discontinued. The patient received platelets due to platelet count being 48; therefore, this was done to help prevent bleeding due to the discontinuation of the catheter. The iab was discarded, and per physicians notes, "the patient remained stable. " there was no report of patient death in relation to this reported event. There as no report of this event being attributed to the intra-aortic balloon pump. A complaint was opened on (b)(4) to report the involved balloon catheter in this event.
 
Manufacturer Narrative
The customer did not request getinge service in connection with this event. However, the customer advised us that the issue was the balloon catheter and not the iabp, thus there was no need for evaluation and/or repair of the involved unit. In addition, the customer reiterated that the information on the pump model and serial number is unavailable.
 
Event Description
Per facility medwatch, it was reported that during intra-aortic balloon pump (iabp) therapy, the intra-aortic balloon catheter (iabc) ruptured. The nurse called the physician and the advanced licensed practitioner to assess the situation and blood was observed marching up the catheter towards the iabp. The iabp then stopped inflating and the iabc was removed from the patient. The patient received platelets due to platelet count being 48; therefore, this was done to help prevent bleeding due to the removal of the catheter and discontinuation of therapy. The iabc was discarded, and per physicians notes, "the patient remained stable. " the exact iabp model/type was not reported to us. A separate report on the involved iabc was submitted under report #2248146-2018-00162.
 
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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 Key7327545
MDR Text Key102016903
Report Number2249723-2018-00380
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 12/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUKNKNOWN
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received03/16/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 03/09/2018 Patient Sequence Number: 1
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