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

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  

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inserting the balloon over the wire, blood was found to be leaking from the center of the balloon.The balloon was withdrawn and found to be filled with blood.The balloon could not be used thereafter.Patient suffered st elevation inferior wall myocardial infarction and "pedaled" on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).

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inserting the balloon over the wire, blood was found to be leaking from the center of the balloon.The balloon was withdrawn and found to be filled with blood.The balloon could not be used thereafter.Patient suffered st elevation inferior wall myocardial infarction and "pedaled" on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).

• Brand Name: CS100
• Type of Device: SYSTEM, 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 Key: 6833214
• MDR Text Key: 84073349
• Report Number: 2249723-2017-00406
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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 Received: 08/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-3013-XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 10/03/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 55 YR