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

Model Number	0052-3014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	10/12/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Conclusion not yet available-evaluation in progress.This initial mdr is being submitted to meet our requirements of reporting.A follow-up will be submitted as soon as the investigation is complete.
Event or Problem Description
Case information: (b)(6) year old male with stemi brought to the hospital.Femoral angiogram performed prior to sheath insertion showing sufficient vessel size.The 14 fr oscor introducer sheath was inserted in the rfa.Iliac dissection was noted post sheath insertion with angiogram.Impella insertion was aborted.The patient did not survive.The sheath was taken away with patient and could not be retrieved.We will not be receiving this product back, so this will be all the information we will be getting regarding the case.
Additional Manufacturer Narrative
The device will not be returned for analysis.The clinical team did not attribute the death to the device.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity and no new failure mode identified.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type.Quality assurance procedure (abiomed introducer sheath) in-process & final inspection: device is tested one hundred percent for cap and seal inspection, a leak test is perform according to procedure, also an occlusion test is perform.Sideport with valve assembly samples are randomly selected for visual inspection: with the naked eye, inspect sideport assembly for excessive glue.Smeared glue to the sideport assembly is not acceptable.Verify the sideport tube is properly bonded to hub and stopcock valve by gently tugging on both joints.Note: if one part fails, one hundred percent inspection of the lot for bond integrity of sideport tube to hub and stopcock valve is required.Instructions for use (ifu), abiomed adelante s2 - hemoslaticp peel away & sideport.Under precaution: 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 sheath with 5 cc of saline immediately before peeling the sheath away in order to minimize back bleeding.

• 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 1816
• MDR Report Key: 6948640
• Report Number: 1035166-2017-00087
• Device Sequence Number: 1141183
• Product Code: DYB
• UDI-Device Identifier: 00813502011562
• UDI-Public: 00813502011562
• 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,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2018

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: Physician
• Device Expiration Date: 05/01/2020
• Device Model Number: 0052-3014
• Device Catalogue Number: 0052-3014
• Device Lot Number: C1-13369
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 03/08/2018
• 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: Death
• Patient Age: 64 YR