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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problems Material Frayed (1262); Difficult to Insert (1316); Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/10/2020
Event Type  malfunction  
Manufacturer Narrative
Event site postal code: (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 # (b)(4).
 
Event Description
It was reported that during the insertion of an intra-aortic balloon (iab), the sheath flared at the tip.The hospital staff attempted to insert a second sheath and the same problem occurred.The hospital staff then continued use with a non-maquet sheath and therapy was provided.There was no reported injury to the patient.This report is for the first iab used.
 
Manufacturer Narrative
Additional information.Section d - unique identifier (udi) # from: [blank] to: (b)(4).Section h - evaluation method codes added: historical data analysis; 4109.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.Reference complaint (b)(4) h3 other text : device not returned.
 
Event Description
It was reported that during the insertion of an intra-aortic balloon (iab), the sheath flared at the tip.The hospital staff attempted to insert a second sheath and the same problem occurred.The hospital staff then continued use with a non-maquet sheath and therapy was provided.There was no reported injury to the patient.This report is for the first iab used.
 
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Brand Name
SENSATION PLUS 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 Key10365372
MDR Text Key202203448
Report Number2248146-2020-00393
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/20/2022
Device Catalogue Number0684-00-0575
Device Lot Number3000099048
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Manufacturer Received09/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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