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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET /DATASCOPE CORP. FIBER OPTIC IAB CATHETER; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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MAQUET /DATASCOPE CORP. FIBER OPTIC IAB CATHETER; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problems Material Rupture (1546); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Failure of Implant (1924)
Event Date 05/27/2022
Event Type  Injury  
Event Description
Intra-aortic balloon ruptured/failed while in use inside a patient's aorta, connected to an intra-aortic balloon pump.Because the patient was dependent on the support of the balloon pump to sustain life, the patient needed to have an emergent procedure to replace the balloon.Fda safety report id # (b)(4).
 
Event Description
Additional information received from a reporter on 06/10/2022 for a report number mw5110227.Of note, this event occurred 2 times on the same patient.The balloon was placed (b)(6) 2022, ruptured (b)(6) 2022, replaced with new (b)(6) 2022, ruptured again on (b)(6) /2022, replaced again with a new one on (b)(6)2022.(second medwatch report filed for the (b)(6) 2022 event).Common cause analysis found that the balloon was placed through the axillary artery, which is an approved, however, atypical insertion site.Also the patient was more physically active than what is typical of patients on an intra-aortic balloon pump, as he need to engage fully with physical therapy while waiting for a heart and kidney transplant.
 
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Brand Name
FIBER OPTIC IAB CATHETER
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
MAQUET /DATASCOPE CORP.
fairfield NJ 07004
MDR Report Key14644891
MDR Text Key293832950
Report NumberMW5110227
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 06/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/26/2022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/08/2022
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/10/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
INTA-AORTIC BALLOON PUMP
Patient Outcome(s) Other; Required Intervention;
Patient Age23 YR
Patient SexMale
Patient Weight58 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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