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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0475
Device Problem Occlusion Within Device (1423)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/22/2017
Event Type  malfunction  
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.We continue our efforts to follow up with the customer for its return.(b)(4).
 
Event Description
It was reported that the cardiologist completed the intra-aortic balloon (iab) insertion procedure.After which blood was found in the tubing.The iab was replaced and therapy continued.The cardiologist tested the catheter and didn't find any signs that the iab was broken.There was no injury or harm to the patient.
 
Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).
 
Event Description
It was reported that the cardiologist completed the intra-aortic balloon (iab) insertion procedure.After which blood was found in the tubing.The iab was replaced and therapy continued.The cardiologist tested the catheter and didn't find any signs that the iab was broken.There was no injury or harm to the patient.
 
Manufacturer Narrative
The product was returned with the membrane loosely folded and blood on the exterior.Dried blood was found occluding the inner lumen.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leak was detected.The evaluation cannot confirm the reported leak, blood in tubing problem.A device and lot history record review was completed for the reported product.No non conformances were found that are considered to be related to the event.(b)(4).
 
Event Description
It was reported that the cardiologist completed the intra-aortic balloon (iab) insertion procedure.After which blood was found in the tubing.The iab was replaced and therapy continued.The cardiologist tested the catheter and didn't find any signs that the iab was broken.The indication for therapy was cardiogenic shock.There was no injury or harm to the patient.
 
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Brand Name
LINEAR 7.5 FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key6855980
MDR Text Key86145368
Report Number2248146-2017-00382
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 12/19/2017
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 No Information
Device Expiration Date02/23/2020
Device Catalogue Number0684-00-0475
Device Lot Number3000046052
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2017
Is the Reporter a Health Professional? Yes
Device AgeYR
Initial Date Manufacturer Received 08/22/2017
Initial Date FDA Received09/11/2017
Supplement Dates Manufacturer Received11/15/2017
12/08/2017
Supplement Dates FDA Received12/12/2017
12/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age68 YR
Patient Weight64
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