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

Model Number 0052-3025

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

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

Event Date 05/28/2019

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

On (b)(6) 2019, patient was presented to physician for cardiac arrest with intermittent return of spontaneous circulation during ems and er intervention.Approximately 1 day after, during acute myocardial infarction / cardiogenic shock, impella implanted and introducer peeled away.As per reported event, introducer was peeled while still in patient's vessel, causing the bleed.Hemostasis was achieved and patient was in stable condition.3 units of blood products were given.Procedure completed successfully with impella cp device.No new introducer was needed.Blood products delivered approximately 1 day after introducer was removed.

Manufacturer Narrative

Device used in treatment.The device was not returned for analysis.The investigation will focus on a review of product documentation.The device passed all in-process and qa final inspection steps before shipping to the customer.The device history record was reviewed to confirm that the device passed all applicable in-process and final inspections.Per procedure adelante s2s introducer sheath in-process and final inspections: visual inspection: verify hub to be smooth, no cracks, short shots, sinking or unfilled areas, and check for fm.Verify hub shape as per drawing.Verify french size is properly embossed on hub.Check for excessive flash (maximum allowable limit is 0.005") and tube pinch (maximum allowable limit is 0.005").Using 10x microscope, look down into hub for irregularities.Verify no splitting at break lines and a smooth transition between sheath and hub on inside of hub.Along the entire length of the hub, verify that there is no break in the molded plastic where the extrusion is visible.Verify presence of the two score lines spaced approximately 180 degree apart around the circumference of sheath tube.Using 10x microscope, look down into the hub and verify score lines on sheath is in perfect alignment with break line of the hub.Verify parts are free from contamination in the form of oil or residue.Per a biomed adelante s2, instructions for use (ifu), it informs the user of these cautions: device is supplied sterile.Do not use if package has been previously opened or damaged.Prior to use, read all package inserts, warnings, precautions, and instructions.Failure to do so may result in severe patient injury or death.Procedure must be performed by trained medical personnel well versed in anatomical landmarks, safe technique, and potential complications.The product is designed for single use only.Do not resterilize or reuse.Do not alter the product in any way.In addition, they list these adverse effects and possible complications: air embolism, bleeding, hematoma formation, and vessel damage.Based on the investigation, a capa is not required as there were no design, labeling or manufacturing related non-conformity found.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.

• Brand Name: INTRODUCER KIT FOR IMPELLA®
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm habror FL 34683
• MDR Report Key: 8760516
• MDR Text Key: 150030200
• Report Number: 1035166-2019-00056
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00813502010664
• UDI-Public: 00813502010664
• Combination Product (y/n): N
• PMA/PMN Number: K122084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: 0052-3025
• Device Catalogue Number: 0052-3025
• Device Lot Number: C1-16097
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR