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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Ischemia (1942)
Event Date 07/18/2019
Event Type  Injury  
Manufacturer Narrative
Our investigation is still in progress, follow up report will be submitted if we find any further additional information.
 
Event Description
It was reported that patient was presented to physician for ejection fraction of 55% dropping to 15%.During high risk percutaneous coronary intervention, the physician made the decision to leave the peel away sheath in the patient's anatomy during support with the impella device.This was done to prevent risk of losing proper positioning of the impella.As a result, the patient's leg became ischemic and the introducer was removed.There was no particular malfunction reported with the device reported, just that patient endured ischemia due to introducer remaining in access site during impella support.To resolve ischemia, physician removed the introducer.Introducer was removed and pump was ultimately removed.No new pump was inserted and patient continued support via inotropic medication.Patient outcome is stable.1 device was planned to introduce on the introducer.
 
Manufacturer Narrative
The device was used for treatment.There was no product performance issue reported.The device was not returned for evaluation,therefore, the clinical observation could not be confirmed.The investigation will focus on the documentation review.The device history records were reviewed to confirm that the devices passed all applicable in process and final inspections.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.Oscor inc.Is submitting the above report to comply with 21 cfr part 803, the medical device reporting regulation.The report is based upon information obtained by oscor inc.Which the company may not have been able to investigate or verify prior to the date the report was required by fda.This report does not constitute an admission that the device, oscor inc., or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, oscor inc., or its employees, that the report constitutes an admission that the device, oscor inc., or its employees caused or contributed to the event described in this report.
 
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Brand Name
INTRODUCER KIT FOR IMPELLA®
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
OSCOR INC.
3816 desoto blvd
palm harbor FL 34683
MDR Report Key8930300
MDR Text Key156407429
Report Number1035166-2019-00072
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00813502010664
UDI-Public00813502010664
Combination Product (y/n)N
PMA/PMN Number
K122084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 10/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/01/2021
Device Model Number0052-3025
Device Catalogue Number0052-3025
Device Lot NumberC1-15824
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/01/2019
Initial Date FDA Received08/26/2019
Supplement Dates Manufacturer Received09/12/2019
Supplement Dates FDA Received10/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age79 YR
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