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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR INC. INTRODUCER KIT FOR IMPELLA INTRODUCER, CATHETER

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OSCOR INC. INTRODUCER KIT FOR IMPELLA INTRODUCER, CATHETER Back to Search Results
Model Number 0052-3021
Device Problems Kinked (1339); Split (2537)
Patient Problems Perforation (2001); Blood Loss (2597)
Event Date 12/08/2017
Event Type  Injury  
Manufacturer Narrative
Conclusion not yet available, evaluation in process. This initial mdr is being submitted to meet our requirements of reporting. A follow-up will be submitted as soon as the investigation is complete.
 
Event Description
The customer reported this introducer was being used for insertion of the impella rp at the femoral vein. The patient was presented to the cath lab for rp placement post coronary artery bypass graft (cabg). When attempting to place the 23fr introducer for rp implant, the introducer was seen to be compromised at insertion and kinked/split. There was an iliac vein perforation, which did require stenting and between 4-6 units of blood product replacement. The devices involved with this procedure were used in the following sequence: 23fr introducer, followed by impella rp and a stent of unknown manufacturer. The outcome of the patient is stable.
 
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Brand NameINTRODUCER KIT FOR IMPELLA
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
OSCOR INC.
3816 desoto blvd.
palm harbor FL 34683 1816
Manufacturer (Section G)
OSCOR INC.
3816 desoto blvd.
palm harbor FL 34683 1816
Manufacturer Contact
dorit segal
3816 desoto blvd
palm harbor, FL 34683-1816
7279372511
MDR Report Key7213306
MDR Text Key98046046
Report Number1035166-2018-00007
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00813502010558
UDI-Public00813502010558
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/01/2019
Device Model Number0052-3021
Device Catalogue Number0052-3021
Device Lot NumberC1-12952
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/23/2018 Patient Sequence Number: 1
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