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

Model Number 0052-3025

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Blood Loss (2597)

Event Date 10/19/2019

Event Type  malfunction  

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 admitted in cardiogenic shock and having acute myocardial infarction.During insertion at femoral artery while advancing 0.035" wire the sheath valve popped out.As per additional information received on, october 23,201 "the valve popped out of the orange retaining ring that holds it in place.The angiographic pigtail catheter that was backloaded on an 0.035" guide wire and was being advanced through the oscor sheath valve.While pushing it through the valve into the body, the valve popped out of its position in the sheath.We had no hemostasis with back bleeding from a straight 14f cannula.The valve failed completely.It was detached from the sheath and up on the pigtail catheter away from the sheath itself about 2-3cm.We removed the pigtail and wire with the valve still on it and placed the dilator in the sheath lumen to control hemostasis.The orange ring was cracked but not at the notch where it breaks when we peel away.Instead, the orange retaining ring failure was over the white sheath wing on the same side as the side arm.Patient loss 75c of blood, no blood products given.No intervention required.No other additional information is available.

Manufacturer Narrative

The following sections were updated in follow-up.B4,g4,g7,h2,h6,h10 the device was used for treatment.The device was not returned for analysis, therefore, the clinical observation could not be confirmed.The investigation will focus on a review of product documentation.Per procedure adelante s2s introducer sheath in-process and final inspections: use a 10x microscope.Along the entire length of the hub, verify that there is no break in the hub's molded plastic where the extrusion is visible.Vacuum leak test - perform pressure and vacuum leak test per procedure latest revision.This testing performed 100% by manufacturing or quality assurance.Per ifu:when assembling the sheath and dilator, care must be taken to insert the dilator tip straight through the center of the valve membrane in order to prevent inadvertent puncturing of the membrane.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.In addition, there was no new failure mode identified and the risk remains acceptable.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: 9355647
• MDR Text Key: 185954115
• Report Number: 1035166-2019-00107
• 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: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Model Number: 0052-3025
• Device Catalogue Number: 0052-3025
• Device Lot Number: C1-14191
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR