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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0470-01
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/16/2020
Event Type  malfunction  
Manufacturer Narrative
Event site postal code: (b)(6). A photo was provided of a damaged guide wire. The actual product was not returned for evaluation. The guide wire in the photo was reviewed and is not a maquet product. The wire that is provided with the maquet sensation 7fr catheter kit is an. 018¿ green guide wire. The damaged guide wire in the provided photos appears to be stainless steel. The reported event cannot be confirmed by the evaluation. 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. 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. Complaint record id # (b)(4).
 
Event Description
It was reported that prior to intra-aortic balloon (iab) therapy, the customer stated the guide wire was faulty. It was reported that it was splintering after coming out of the packaging. There was no patient harm or adverse event reported.
 
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Brand NameSENSATION 7FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
dorota wolpiuk
15 law drive
fairfield, NJ 07004
MDR Report Key10970717
MDR Text Key227654864
Report Number2248146-2020-00652
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/18/2019
Device Model Number0684-00-0470-01
Device Catalogue Number0684-00-0434
Device Lot Number3000104733
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/18/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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