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

Model Number	0052-3001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Myocardial Infarction (1969); Tachycardia (2095); Cardiogenic Shock (2262)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up report will be submitted as soon as the investigation is complete.
Event or Problem Description
It was reported patient came from intensive care unit (icu) in a rather critical state.The 23f sheath was used for acute myocardial infraction (ami) and a cardiogenic shock (cgs) procedure.Issue with the 23f sheath was bleeding through the valve, it was identified when sheath was inserted into the femoral vein, physician tried to stop bleeding with 0.027" wire (different vendors product), then 12f sheath, then rp pump (in that order) unsuccessfully.Only brief delay of the procedure due to bleeding, no impact on patient condition.Patient outcome is death ((b)(6) 2020), however, death is not related to device failure.Physician reported cause of patient death as ventricular tachycardia (attempts to achieve sinusrhythm were unsuccessful) followed by no output from left ventricle (lv).Additionally, the physician said that the blood loss was not contributing to the death of the patient since it was not therapeutically relevant.
Additional Manufacturer Narrative
The device was used in treatment.The device was not returned for analysis, as it was discarded.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 procedure abiomed introducer sheath in-process and final inspections: 12.3 vacuum leak test: perform pressure and vacuum leak test per procedure, latest revision.This procedure is performed by qa 100%.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.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 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: ABIOMED INTRODUCER KIT FOR IMPELLA
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor, fl
• MDR Report Key: 10259632
• Report Number: 1035166-2020-00040
• Device Sequence Number: 11413826
• Product Code: DYB
• UDI-Device Identifier: 00813502011517
• UDI-Public: 00813502011517
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: 0052-3001
• Device Catalogue Number: 0052-3001
• Device Lot Number: C1-14497
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1