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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0469-01
Device Problem Difficult to Remove (1528)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/31/2023
Event Type  malfunction  
Manufacturer Narrative
Occupation: cardiac cath lab manager.Additional contact person information: (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id#: (b)(4).H3 other text : device not returned.
 
Event Description
It was reported that the customer experienced difficulty removing the intra-aortic balloon (iab) after a successful pci angioplasty and placing two stents.Dilatation of the entry point was required in order to get the distal tip of the iab through the femoral artery.This resulted in injury to the patient's arteriotomy site and significant bleeding.The patient was given blood products.Sheering of the device was noted.The physician was concerned that there was "metal" at the distal tip of the iab.Upon inspection, the getinge representative noticed the iab had a sheath still attached between the base of the iab membrane and the white y-fitting of the iab.The sheath was blue in color and had a side port attached to it.This sheath was not the provided getinge sheath.At the distal tip of the iab, the membrane appeared to be cut open, which was cut by the customer after removal in order to inspect it.Medwatch#: (b)(4).Iabp was placed at an outside facility.Patient was transferred to this hospital for further interventional treatment.Pci angioplasty conducted.Two stents placed successfully.Attempted to remove the balloon pump but the distal tip would not come through the femoral artery.Able to remove after dilatation of the entry point which resulted in significant bleeding.Sheering of the device noted.
 
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint # (b)(4).
 
Event Description
N/a.
 
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Brand Name
SENSATION 7FR. 34CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer Contact
brian schaeffer
15 law drive
fairfield, NJ 
MDR Report Key16806318
MDR Text Key313911375
Report Number2248146-2023-00279
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567106755
UDI-Public10607567106755
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 06/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/11/2023
Device Model Number0684-00-0469-01
Device Catalogue Number0684-00-0433
Device Lot Number3000136901
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/03/2023
Initial Date FDA Received04/25/2023
Supplement Dates Manufacturer Received06/29/2023
Supplement Dates FDA Received06/29/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/11/2020
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NON-GETINGE SHEATH
Patient Outcome(s) Required Intervention;
Patient Age68 YR
Patient SexFemale
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