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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0474
Device Problem Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/05/2018
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.(b)(4).
 
Event Description
It was reported that intra-aortic balloon (iab) there was resistance while withdrawing blood to ensure lumen patency.Correct positioning of the catheter was verified by x-ray.The iab was replaced to resolve the problem.The indication for use was cabg (coronary artery bypass graft).There was no reported injury to the patient.
 
Event Description
It was reported that intra-aortic balloon (iab) there was resistance while withdrawing blood to ensure lumen patency.Correct positioning of the catheter was verified by x-ray.The iab was replaced to resolve the problem.The indication for use was cabg (coronary artery bypass graft).There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane loosely folded and blood found on the exterior of the catheter.The insertion kit was also returned unused seal and intact.One kink was found on catheter tubing and inner lumen near the y-fitting approximately 76.5cm from the iab tip.The technician attempted to flush/aspirate the inner lumen and was unable to do so.The technician then attempted to insert a 0.025¿ laboratory guide wire through the inner lumen and resistance was only felt at the kinked location.The condition of the iab as received indicated a kink on the catheter tubing and inner lumen.This can cause difficulty during aspiration of the inner lumen.The evaluation confirmed the reported problem.We are unable to determine when this may have occurred.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).
 
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Brand Name
LINEAR 7.5 FR. 34CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key7388050
MDR Text Key104268515
Report Number2248146-2018-00220
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,distri
Type of Report Initial,Followup
Report Date 04/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/14/2020
Device Catalogue Number0684-00-0474
Device Lot Number3000055094
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2018
Device AgeYR
Date Manufacturer Received04/02/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age59 YR
Patient Weight58
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