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

Model Number	0052-3025
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Ischemia (1942); Blood Loss (2597)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used in 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.The device history record was reviewed to confirm that the device passed all applicable in-process and final inspections.As per procedure adelante s2s introducer sheath in-process and final inspection: vacuum leak test - perform pressure and vacuum leak test per procedure.This test is performed by qa on 100% of the product.Per instructions for use (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.Dilators, catheters, and pacing leads should be removed slowly from the sheath.Rapid removal may damage the valve membrane resulting in blood flow through the valve.As per ifu bleeding 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 required.
Event or Problem Description
It was reported that patient was admitted pre-operative placement of the impella prior to coronary artery bypass grafting surgery.Introducer was used for insertion at the right femoral artery for an impella cp.The physician had to leave 14fr oscor in for 2 days from 25th february to 27th february, with external bypass placed to reduce limb ischemia, on 27th february blood loss was noticed at the introducer which saturated the groin site dressing.The blood loss was occurring through the valve of the introducer sheath.The amount of blood loss is unknown.The patient received 1 unit of blood replacement.Bleeding required introducer explant and advancement of the impella repositioning sheath.During explant of introducer vessel damage was observed, as per physician vessel damage is related to patient movement.Patient was taken to hybrid or to surgically repair impella cp access site in the right leg.Right femoral, and right profunda surgical patch and right lower extremity thromboembolectomy and removal of atherosclerotic plaque was performed.Patient maintained hemodynamic stability through the surgical procedure and was taken to icu.Procedure completed with another introducer and pump from other leg.No additional information is available and no other adverse event reported.

• Brand Name: ABIOMED 14F INTRODUCER KIT FOR IMPELLA
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• MDR Report Key: 8475868
• Report Number: 1035166-2019-00028
• Device Sequence Number: 1474389
• Product Code: DYB
• UDI-Device Identifier: 00813502010664
• UDI-Public: 00813502010664
• 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: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2019

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: 10/01/2021
• Device Model Number: 0052-3025
• Device Catalogue Number: 0052-3025
• Device Lot Number: C1-15224
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/02/2019
• 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
• Patient Age: 53 YR