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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-3013-XX
Device Problem Leak/Splash (1354)
Patient Problems Death (1802); Myocardial Infarction (1969); Cardiogenic Shock (2262); Blood Loss (2597)
Event Date 08/12/2017
Event Type  Death  
Event Description
While inserting a maquet intra aortic balloon in a case of st elevation (heart rate) inferior wall myocardial infarction with cardiogenic shock in our cath lab on (b)(6)2017 through femoral sheath provided with the balloon, there was a serious device malfunction. While inserting the balloon over the wire, blood was found to be leaking from the center of the balloon. The balloon was withdrawn and found to be filled with blood. The balloon could not be used thereafter. Patient suffered st elevation inferior wall myocardial infarction and "pedaled" on double inotropic support in cardiogenic shock. She was taken for cag (coronary artery graft coronary angiography) with backup tpi & iabp (intra-aortic balloon pump). It was reported that the patient died on (b)(6)2017. The death is not being attributed to the iabp but the iab catheter. There is no alleged malfunction of the iabp. Please reference related balloon complaints 146128 and 146149.
 
Manufacturer Narrative
10/05/2017 04:41 pm (gmt-4:00) added by (b)(4) (pid-(b)(4)): please note the (b)(4) updated is now (b)(4). 10/04/2017 04:46 pm (gmt-4:00) added by (b)(4) (pid-(b)(4)): the production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformance's related to the reported event were noted. The company business unit in india reported that the customer did not register a complaint against the intra-aortic balloon pump and that it is in clinical use. As such there was no evaluation done on the iabp.
 
Event Description
While inserting a maquet intra aortic balloon in a case of st elevation (heart rate) inferior wall myocardial infarction with cardiogenic shock in our cath lab on (b)(6)2017 through femoral sheath provided with the balloon, there was a serious device malfunction. While inserting the balloon over the wire, blood was found to be leaking from the center of the balloon. The balloon was withdrawn and found to be filled with blood. The balloon could not be used thereafter. Patient suffered st elevation inferior wall myocardial infarction and "pedaled" on double inotropic support in cardiogenic shock. She was taken for cag (coronary artery graft coronary angiography) with backup tpi & iabp (intra-aortic balloon pump). It was reported that the patient died on (b)(6)2017. The death is not being attributed to the iabp but the iab catheter. There is no alleged malfunction of the iabp. Please reference related balloon complaints (b)(4) and (b)(4).
 
Manufacturer Narrative
Additional information has been requested, and we will report accordingly if it becomes available. The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not reviewed as the serial number of the iabp was not provided by the event site.
 
Event Description
While inserting a maquet intra aortic balloon in a case of st elevation (heart rate) inferior wall myocardial infarction with cardiogenic shock in our cath lab on (b)(6) 2017 through femoral sheath provided with the balloon, there was a serious device malfunction. While inserting the balloon over the wire, blood was found to be leaking from the center of the balloon. The balloon was withdrawn and found to be filled with blood. The balloon could not be used thereafter. Patient suffered st elevation inferior wall myocardial infarction and "pedaled" on double inotropic support in cardiogenic shock. She was taken for cag (coronary artery graft coronary angiography) with backup tpi and iabp (intra-aortic balloon pump). It was reported that the patient died on (b)(6) 2017. The death is not being attributed to the iabp but the iab catheter. There is no alleged malfunction of the iabp. Please reference related balloon complaints (b)(4).
 
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Brand NameCS100
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 Key6833214
MDR Text Key104291177
Report Number2249723-2017-00406
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0998-00-3013-XX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received10/03/2017
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: 08/30/2017 Patient Sequence Number: 1
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