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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 Restricted Flow rate (1248); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/05/2020
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.Reference complaint: (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, there was a "restriction" alarm generated and blood visible in the iab tubing.The iab was replaced and therapy was provided.There was no reported injury to the patient.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, there was a "restriction" alarm generated and blood visible in the iab tubing.The iab was replaced and therapy was provided.There was no reported injury to the patient.
 
Manufacturer Narrative
Additional information: added unique identifier (udi):(b)(4).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.Reference complaint (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, there was a "restriction" alarm generated and blood visible in the iab tubing.The iab was replaced and therapy was provided.There was no reported injury to the patient.
 
Manufacturer Narrative
A cut/separated portion of the product was returned with the membrane completely unfolded with blood on the exterior and interior of the catheter.The cut/separation was made at the catheter tubing at approximately 43.4cm from the iab tip.At this same location, the inner lumen and optical fiber were also cut/separated.An underwater leak test of the balloon and partial catheter tubing was performed and one leak was detected on the membrane approximately 1.4cm from the rear seal and measuring approximately 0.04cm in length.The reported problem was most likely triggered by the leak found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark caused by a calcified plaque in the aorta.The evaluation confirmed the reported problem.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint # (b)(4).
 
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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 Key10338725
MDR Text Key201402351
Report Number2248146-2020-00381
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,health
Type of Report Initial,Followup,Followup
Report Date 10/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0684-00-0575
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2020
Was the Report Sent to FDA? Yes
Date Manufacturer Received09/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age76 YR
Patient Weight70
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