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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 0684-00-0475
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Patient Involvement (2645)
Event Date 11/30/2017
Event Type  malfunction  
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. Complaint # (b)(4).
 
Event Description
It was reported that there was a guide wire insertion abstraction during a service visit/demo of the equipment by a company representative. There was no patient involvement and therefore no risk of injury.
 
Manufacturer Narrative
Iab insertion kit batch was 3000032184, manufactured 6/28/2016, expiration date 6/28/2021. Device evaluation: the product was returned with the membrane loosely folded and traces of blood on the exterior of the catheter with the one-way valve attached. The stylet wire was also returned partially inside the iab lumen. 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 of the returned iab and found that the inner lumen was occluded. The technician was able to clear the occlusion and dried blood was observed at the tip of the guide wire. The condition of the iab as received indicated an occlusion in the inner lumen. A review of the provided video supports the inner lumen occlusion. The evaluation confirmed the reported problem. Blood clotting within the inner lumen will seal the passage. It is difficult to determine when the occlusion occurs, however, if this occurs during the procedure it will be impossible to flush or aspirate through the inner lumen. It can also cause poor or no pressure waveform and guide wire insertion difficulty. 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. Complaint # (b)(4).
 
Event Description
It was reported that there was a guide wire insertion abstraction during a service visit/demo of the equipment by a company representative. There was no patient involvement and therefore no risk of injury.
 
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 there was a guide wire insertion abstraction during a service visit/demo of the equipment by a company representative. There was no patient involvement and therefore no risk of injury.
 
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Brand NameLINEAR 7.5 FR. 34CC IAB
Type of DeviceSYSTEM, 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 Key7144897
MDR Text Key252106450
Report Number2248146-2017-00732
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/29/2019
Device Catalogue Number0684-00-0475
Device Lot Number3000031898
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received02/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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