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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR INC ABIOMED INTRODUCER 14F S13CM D18CM TKIT INTRODUCER, CATHETER

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OSCOR INC ABIOMED INTRODUCER 14F S13CM D18CM TKIT INTRODUCER, CATHETER Back to Search Results
Lot Number OR-04735
Device Problem Device Damaged Prior to Use (2284)
Patient Problem Hemostasis (1895)
Event Date 09/28/2017
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
I would like to inform you of a complaint on the 14fr sheath that has been determined to be reportable due to the patient having significant groin bleeding that required vasculature to be repaired surgically. They physician was concerned that the damage to the sheath may have caused the damage to the artery. Abiomed does not have this product returned from the field at this time. I have listed the full salesforce narrative below. Please let me know if you have any questions. I believe there will be more information when the part returns from the field. Pt presented to ed nstemi early morning. Taken into cv lab to assess. Pt de-compensated and impella was placed per protocol. The 14fr sheath had some damage before use but was used due to no back up sheath and placed before i arrived. Coronaries were found to have severe disease in lad and rca, disease in circ balloon and des x3 to lad. Balloon and des to rca. At the end of the successful revasc peel away sheath was removed and repo sheath was placed. Pt's groin continued to bleed. Manual compression was held for over an hour but it would not stop. Phys was concerned that there may be damage to the artery from the 14fr sheath. Because the pt was doing well it was decided that impella would be removed in operating room (or) and artery surgically repaired. Impella was successfully weaned and removed in operating room (or). Sheath to be sent back to be examined. (b)(6) on site. What is the lot number of the device used? introducer kit, 14 fr, sterile (batch: or-04735) what is the name, model no. And lot no. For any additional device used during the procedure? only the impella cp and 14fr oscor sheaths were used. Are the devices available to return to oscor for evaluation? the 14fr sheath was returned for investigation to abiomed but will not be returned to oscor as it is a gen 1 sheath. Only gen 2 sheaths will be returned to oscor as those are our currently used sheaths.
 
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Brand NameABIOMED INTRODUCER 14F S13CM D18CM TKIT
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
MDR Report Key7000647
MDR Text Key91011666
Report Number1035166-2017-00093
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 distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberOR-04735
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/03/2017 Patient Sequence Number: 1
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