MAUDE Adverse Event Report: OSCOR INC. ABIOMED 14F INTRODUCER KIT FOR IMPELLA; INTRODUCER, CATHETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemostasis (1895); Blood Loss (2597)

Event Date 02/08/2019

Event Type  Injury  

Manufacturer Narrative

Device used in treatment.The device was not returned for analysis.There was no specific performance related failure reported by the user.The lot number of this device was not provided, therefore neither a review of the device history record nor complaint history could be performed.Inspection procedures require any oscor product pass all in-process and qa final inspections before shipping to the customer.As per ifu: directions for use: introducer removal flush the sheath with 5 cc of saline immediately before peeling the sheath away in order to minimize back bleeding.First, completely withdraw the sheath from the vessel.Then remove the sheath by sharply snapping the tabs of the valve housing in a plane perpendicular to the long axis of the sheath to split the valve and peel the sheath apart.As per ifu: bedding is possible complications/adverse effects.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.No further follow-up is require.

Event Description

It was reported that patient was presented to the physician for ami w/shock-impella post-pci.During the procedure sheath placed to left femoral artery, when long sheath (14f) was peeled away, bleeding happen.There was 300cc blood lost and rbc 2u transfusion was made.No additional surgery or medical intervention required to control the blood loss.Bleeding was treated with manual compression hemostasis and inserted a sheath for insertion.There was unknown time of delay reported because of blood transfusion.There was no specific device performance failure reported by the user, the peel away sheath peeled all the way through.Impella support was successful and patient outcome is stable.No additional information is available and no other adverse event reported.

• Brand Name: ABIOMED 14F INTRODUCER KIT FOR IMPELLA
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd; palm habror FL 34683
• Manufacturer Contact: doug myers ; 3816 desoto blvd; palm habror, FL 34683 ; 7279372511
• MDR Report Key: 8401049
• MDR Text Key: 138144760
• Report Number: 1035166-2019-00022
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR