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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 Problems Entrapment of Device (1212); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2018
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.(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) preparation for insertion, a retainer tube remained on iab catheter after removing it from the t-handle retainer.During iab insertion, it was noticed that iab was difficult to advance further.The reporter was advised to remove the iab catheter and insert the another iab.The position of iab catheter was checked using transoesophageal echocardiogram (toe) and it was in the correct position.Therefore it was decided not to exchange the iab and therapy was able to be provided.There was no reported injury to the patient.
 
Event Description
It was reported that during intra-aortic balloon (iab) preparation for insertion, a retainer tube remained on iab catheter after removing it from the t-handle retainer.During iab insertion, it was noticed that iab was difficult to advance further.The reporter was advised to remove the iab catheter and insert the another iab.The position of iab catheter was checked using transoesophageal echocardiogram (toe) and it was in the correct position.Therefore it was decided not to exchange the iab and therapy was able to be provided.There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.One retainer tube was observed over the catheter tubing.The t-handle was also returned separate with two retainer tubes inside.No damage was observed on the membrane or inner lumen.The retainer tubes were evaluated and found to be within dimensional specification.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.The evaluation confirmed the retainer over the catheter tubing.We are unable to determine how this may have occurred.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) preparation for insertion, a retainer tube remained on iab catheter after removing it from the t-handle retainer.During iab insertion, it was noticed that iab was difficult to advance further.The reporter was advised to remove the iab catheter and insert the another iab.The position of iab catheter was checked using transoesophageal echocardiogram (toe) and it was in the correct position.Therefore it was decided not to exchange the iab and therapy was able to be provided.There was no reported injury 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).
 
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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
MDR Report Key8050967
MDR Text Key128211597
Report Number2248146-2018-00641
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 01/10/2019
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 Date07/05/2021
Device Catalogue Number0684-00-0475
Device Lot Number3000077101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2018
Device Age YR
Initial Date Manufacturer Received 10/16/2018
Initial Date FDA Received11/08/2018
Supplement Dates Manufacturer Received11/14/2018
01/09/2019
Supplement Dates FDA Received12/11/2018
01/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age69 YR
Patient Weight89
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