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

Model Number	0052-3025
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Ischemia (1942); Cardiogenic Shock (2262); Blood Loss (2597)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was used in treatment.The device will not be returned for analysis, therefore, the clinical observation could not be confirmed.The investigation will focus on a review of product documentation.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Per qa adelante-s2s introducer sheath in process and final inspection procedure: preform occlusion test per procedure, per latest revision.Visual inspection: with the naked eye at a distance of 12" to 18", inspect sideport assembly for excessive glue.A bead of glue around the perimeter of the sideport tube to hub joint is acceptable.Smeared glue on sideport assembly is not acceptable.The instructions for use (ifu) instructs the user: aspiration and saline flushing of the sheath, dilator, and valve should be performed to help minimize the potential for air embolism and clot formation.Aspirate all air from the sheath valve assembly by using a syringe connected to the sideport.Flush the introducer through the sideport.If the introducer is to remain in place during catheter positioning and testing, flushing the introducer via the sideport periodically with saline is advised.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.Oscor will continue to monitor this event type.
Event or Problem Description
It was reported that an incident occurred during a surgical procedure for placement of an impella on (b)(6) 2019.After the procedure was over (amifostine, cardiogenic shock impella insertion), while the patient was in icu, the patient's leg was cold and the pulse was absent.The patient went back to the cath lab for the contralateral bypass for limb ischemia.The patient was draped in standard fashion.The oscor sheath 14f x 25cm was inserted into the right femoral artery, the impella was placed through that.Oozing occurred at the insertion site, preventing us from peeling away.Continuous oozing at the sheath site resulted in transfusion; two units of red blood cells was given and an estimated amount of blood loss 4 grams of hemoglobin.The oscor sheath 14f x 25cm was occlusive (not allowing blood flow to pass and down the leg).We then placed a terumo rabbi sheath that is 45cm long in the left femoral artery, advanced the distal tip past the oscor sheath and down the right common femoral artery to provide distal flow to the lower leg.Blood loss was resolved after impella and sheath were removed, perclose deployed.Left femoral artery procedure took approximately 1 hour.Outcome of patient is alive and doing well.Device will not be returned as it was discarded.

• 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: 8499284
• Report Number: 1035166-2019-00031
• Device Sequence Number: 11230357
• 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: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2019

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: 07/01/2021
• Device Model Number: 0052-3025
• Device Catalogue Number: 0052-3025
• Device Lot Number: C1-15070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/10/2019
• 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: 50 YR