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

Model Number	0052-3025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	01/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used in treatment.The device was not returned for analysis.The device history record was reviewed to confirm that the device passed all applicable in-process and final inspections.There was no specific performance related failure reported by the user.The device passed all in-process and qa final inspection steps before shipping to the customer.No further investigation is required.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 on (b)(6) 2019, an (b)(6) male was having a high risk percutaneous coronary insertion procedure.During the procedure, the physician used a 14 french, 25 cm length oscor peel-away introducer.The peel-away sheath was left in access site during the procedure.An echo revealed the device's position was too shallow, and therefore the peel-away was removed by the physician to have better stability.Shortly after removal, a slight ooze developed into a growing hematoma.They physician suspected a tear in the patient's artery was to blame, caused by sheath removal.However, it should be noted that the arterial tear was only suspected and never confirmed.No blood products or additional intervention was required to remedy the bleed, besides early removal of the impella cp pump and site closure.Patient is in stable condition and did not endure any lasting harm.The peel-away sheath was discarded.

• Brand Name: ABIOMED 14F INTRODUCER KIT FOR IMPELLA
• Common Device Name: INTROUDCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 8366170
• Report Number: 1035166-2019-00012
• Device Sequence Number: 19338915
• 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): 02/25/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: 0052-3025
• Device Catalogue Number: 0052-3025
• Device Lot Number: C1-14552
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/25/2019
• 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: Other
• Patient Age: 89 YR