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

Model Number	0052-3000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up will be submitted as soon as the investigation is complete.
Event or Problem Description
During setup of the system, while only 0.18" wire was in the 14f introducer, bleeding through the valve started.After impella placement the bleeding increased.Intervention needed, procedure was restarted with utilization of a new introducer kit due to the heavy bleeding through the first one damaged.Procedure was completed.No transfusion was performed on the patient.Product was discarded.
Additional Manufacturer Narrative
The following sections were updated in follow-up 1: b4, d10, g4, g7, h2, h3, h6 and h10: the device was used in treatment.Upon initial inspection, the hemostatic valve was observed to be slightly damaged.The valve was then inspected in more detail under 10x magnification.The damage was found to be a tear that stemmed off of the valve split line.No leakage was found from the valve or hub when manually leak tested at the site where the sideport tubing and stopcock attaches to the hub.This test was then repeated the same way, but with a guidewire inserted into the introducer as stated in the event description summary.Still there was no leakage observed.Device analysis revealed the 14f abiomed introducer sheath is within manufacturing specifications.The device passed leak testing that was performed per applicable iso standard.The reason for return cannot be confirmed.No manufacturing defects were found.Per adelante s2s introducer sheath in-process and final inspection vacuum leak test - perform pressure and vacuum leak test per procedure latest revision.This test is performed by qa on 100% of the product.The instructions for use (ifu) informs the user: precautions: 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.Directions for use: slowly retract the guidewire and dilator, leaving the sheath in position.The hemostasis valve will reduce the loss of blood and the inadvertent aspiration of air through the sheath.Introduce the catheter through the hemostasis valve/sheath and advance it into position.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: ABIOMED INTRODUCER KIT FOR IMPELLA
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• MDR Report Key: 9315868
• Report Number: 1035166-2019-00097
• Device Sequence Number: 1961959
• Product Code: DYB
• UDI-Device Identifier: 00813502011562
• UDI-Public: 00813502011562
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K122084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: 0052-3000
• Device Catalogue Number: 0052-3000
• Device Lot Number: C1-17434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention