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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0296-01
Device Problem Filling Problem (1233)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/20/2021
Event Type  malfunction  
Manufacturer Narrative
Complete event site name: (b)(6).Additional initial reporter name: (b)(6).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated an auto-fill failure alarm.The customer used three different consoles and replaced the iab, but the issue continued.The pump would attempt to pump a few labored inflations and then alarm autofill failure.The one-way valve was removed, helium extension tubing verified, connections secured, helium was adequate, and there were no signs of blood in the helium tubing.The customer stated that they did not believe there was any kinks in the catheter or tubing and there was no known tortuosity in the patient's aortoiliac junction.It was noted that they had used the sheath that came with the iab insertion kit.The customer eventually removed the second iab and placed a new impella device from a different manufacturer.Patient was and is hemodynamically stable.There was no patient harm or adverse event reported.This report is for the second iab used in this event.A separate report will be submitted for the first iab used.
 
Manufacturer Narrative
Additional information: patient date of birth, weight additional contact person: cactus steelman, risk manager, cactus.Steelman@bsahs.Org date of event from march 21,2021 to march 20,2021 the device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated an auto-fill failure alarm.The customer used three different consoles and replaced the iab, but the issue continued.The pump would attempt to pump a few labored inflations and then alarm autofill failure.The one-way valve was removed, helium extension tubing verified, connections secured, helium was adequate, and there were no signs of blood in the helium tubing.The customer stated that they did not believe there was any kinks in the catheter or tubing and there was no known tortuosity in the patient's aortoiliac junction.It was noted that they had used the sheath that came with the iab insertion kit.The customer eventually removed the second iab and placed a new impella device from a different manufacturer.Patient was and is hemodynamically stable.There was no patient harm or adverse event reported.This report is for the second iab used in this event.A separate report will be submitted for the first iab used.Medwatch mw5100635 received april 27,2021.Autofill error.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded with traces of blood on the exterior of the catheter.The extracorporeal tubing was cut in pieces at approximately 7.11cm from the iab tip.The cut tubing section and extender tubing were also returned.A catheter tubing/inner lumen kink and a flattened/indented section on the catheter tubing were also observed at approximately 33.53cm & 43.69cm from the iab tip respectively.An underwater leak test of the balloon, catheter tubing, y-fitting and extender tubing was performed and no leaks were detected.Unable to leak test the returned extracorporeal tubing due its returned condition.The iab was placed on the cs300 with a laboratory extracorporeal tubing and pumped for two hours, which represents one complete autofill cycle.The iab pumped normally, no alarm sounded.The reported event cannot be confirmed by the evaluation.However, a cut, kinked and/or flattened catheter or extracorporeal tubing may contribute to pump alarms.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period apr-19 through mar-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #: (b)(4).
 
Event Description
N/a.
 
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Brand Name
MEGA 8FR. 50CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
MDR Report Key11633665
MDR Text Key244878007
Report Number2248146-2021-00226
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108001
UDI-Public10607567108001
Combination Product (y/n)N
PMA/PMN Number
K091449
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 08/03/2021
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 Date12/20/2022
Device Model Number0684-00-0296-01
Device Catalogue Number0684-00-0497
Device Lot Number3000111228
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2021
Initial Date Manufacturer Received 03/21/2021
Initial Date FDA Received04/08/2021
Supplement Dates Manufacturer Received04/27/2021
08/03/2021
Supplement Dates FDA Received05/19/2021
08/03/2021
Patient Sequence Number1
Treatment
CARDIOSAVE & IMPELLA DEVICE.
Patient Age70 YR
Patient Weight80
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