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

Model Number	0052-3021
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	02/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was used for treatment.The device was discarded and there was no specific device performance related failure reported by the user.Cause of the bleeding is related to non oscor device used in procedure.The investigation will focus on a review of product documentation.The device history record was reviewed to confirm that the device passed all applicable inprocess and final inspections.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.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.
Event or Problem Description
It was reported that patient was presented to physician for right ventricle (rv) failure.Acute myocardial infarction (ami)/cardiogenic shock (cgs) procedure there was bleeding at the sheath insertion site while using a 23 fr introducer.Femstop was applied after 30 plus minutes of manual pressure.Femstop was removed by cardiothoracic surgery (ct) surgeon.Ct surgeon added additional mattress suture, then re-applied femstop.Patient loose 250cc of blood loss.Initially the sutures placed by the ic were probably shallow to the skin.The surgical pa and ct surgeon went deeper with their sutures.They did an ultrasound to confirm that there was not a perforation.Femstop was in place for 6 hours and hemostasis achieved.The patient was on support for four (4) days.There was no product performance issue reported.As per physician, size discrepancy between the rp pump and the repo sheath was the cause for the bleed.No other intervention was needed.No additional information is available.

• Brand Name: INTRODUCER KIT FOR IMPELLA®
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm harbor, fl
• MDR Report Key: 9813687
• Report Number: 1035166-2020-00019
• Device Sequence Number: 2770566
• Product Code: DYB
• UDI-Device Identifier: 00813502010558
• UDI-Public: 00813502010558
• Combination Product (Y/N): N
• 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): 03/10/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2021
• Device Model Number: 0052-3021
• Device Catalogue Number: 0052-3021
• Device Lot Number: C1-14183
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/10/2020
• 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
• Patient Age: 84 YR