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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 0052-3025-JP
Device Problems Fluid/Blood Leak (1250); Material Too Rigid or Stiff (1544); Device Damaged by Another Device (2915)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/11/2021
Event Type  malfunction  
Manufacturer Narrative
Conclusion not yet available, evaluation in process. A follow-up will be submitted as soon as the investigation is complete.
 
Event Description
It was reported that a (b)(6) male underwent a ami/cgs procedure and at the time of the impella insertion, a long 14fr introducer was inserted into the body, and when trying to insert impella, the hemostatic valve was damaged and there was a side leak of blood, so the sheath was to be reinserted. Since it was not possible to pass through the bent part in the sheath, it was decided to issue a new 14fr introducer. There was no delay in the procedure and there was no patient harm reported. The issue was resolved using another introducer.
 
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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 34683 1816
Manufacturer Contact
doug myers
3816 desoto blvd.
palm harbor, FL 34683-1816
7279372511
MDR Report Key12432959
MDR Text Key270191839
Report Number1035166-2021-00088
Device Sequence Number1
Product Code DYB
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 Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0052-3025-JP
Device Catalogue Number0052-3025-JP
Device Lot NumberDP-12994
Was Device Available for Evaluation? No
Date Manufacturer Received01/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/10/2021
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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