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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 Consequences Or Impact To Patient (2199)
Event Date 12/14/2020
Event Type  malfunction  
Manufacturer Narrative
(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).
 
Event Description
It was reported that upon insertion of the intra-aortic balloon (iab), the console generated an auto-fill failure alarm.The customer noted that they had already swapped out the console and replaced the iab with a new one, but the issue continued.It was verified that there was no blood seen in the tubing, all connections were secure, the one-way valve was removed, helium tank was turned on, helium volume, ecg, and arterial pressure waveforms were present.The customer then confirmed that the first iab functioned as expected outside of the patient.The customer later reported that they had found extreme vessel tortuosity and plaque in the aorta-iliac junction of the patient as well as a possible large clot in that same location.The customer then removed the second iab from the right femoral artery and tried inserting it on the opposite side in the left femoral artery, but received an auto-fill failure alarm once again.Troubleshooting began again and all the same points were verified.It was then noted that the customer used another manufacturer's sheath while inserting the iab into the left femoral artery.The 1st iab was then connected once again to verify the console operated correctly, which it did.The customer was then instructed to insert a third iab.During insertion of the third iab, it was revealed that the sheath used to insert the second iab was too long and not allowing the iab to fully exit the sheath resulting in the auto-fill failure alarm the customer had been receiving.The customer was then instructed to use the sheath that came with the iab.The sheath and iab were both inserted successfully and began auto-filling as expected.There was no patient harm or adverse event reported.This reported is for the second iab used in this event.A separate reported for the first iab used has been submitted under mfg report number.2248146-2021-00002.
 
Event Description
It was reported that upon insertion of the intra-aortic balloon (iab), the console generated an auto-fill failure alarm.The customer noted that they had already swapped out the console and replaced the iab with a new one, but the issue continued.It was verified that there was no blood seen in the tubing, all connections were secure, the one-way valve was removed, helium tank was turned on, helium volume, ecg, and arterial pressure waveforms were present.The customer then confirmed that the first iab functioned as expected outside of the patient.The customer later reported that they had found extreme vessel tortuosity and plaque in the aorta-iliac junction of the patient as well as a possible large clot in that same location.The customer then removed the second iab from the right femoral artery and tried inserting it on the opposite side in the left femoral artery, but received an auto-fill failure alarm once again.Troubleshooting began again and all the same points were verified.It was then noted that the customer used another manufacturer's sheath while inserting the iab into the left femoral artery.The 1st iab was then connected once again to verify the console operated correctly, which it did.The customer was then instructed to insert a third iab.During insertion of the third iab, it was revealed that the sheath used to insert the second iab was too long and not allowing the iab to fully exit the sheath resulting in the auto-fill failure alarm the customer had been receiving.The customer was then instructed to use the sheath that came with the iab.The sheath and iab were both inserted successfully and began auto-filling as expected.There was no patient harm or adverse event reported.This reported is for the second iab used in this event.A separate reported for the first iab used has been submitted under mfg report number.2248146-2021-00002.
 
Manufacturer Narrative
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.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.The device meets all product specifications.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Complaint record id # (b)(4).
 
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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 07004
MDR Report Key11109556
MDR Text Key245099074
Report Number2248146-2021-00003
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
Report Date 01/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0684-00-0296-01
Device Catalogue Number0684-00-0497
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CARDIOSAVE
Patient Age71 YR
Patient Weight75
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