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

Model Number	0052-3000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Death (1802); Cardiogenic Shock (2262)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion not yet available, our investigation is still in progress.A follow-up report will be submitted as soon as the investigation is complete.
Event or Problem Description
It was reported the patient was presented to the physician with hemodynamic support for cardiogenic shock (cgs) and the clinic decided to implant impella cp.Before using the abiomed 14f introducer, they used terumo radufocus introducer ii with 8f.The obturator part had been introduced without problems, everything runs in normal way.As they used the 14f introducer, they dilate with 10f / 12f.Then they took the 14f introducer peel away system.Before launching in the vessel, the top of the peel away system split in two pieces.So they took a second peel away system and everything runs normal.Customer reported no medical or surgical intervention was reported, however there was a delay for several minutes.On (b)(6), 2020, the customer reported the therapy stopped the following night and the patient expired on friday, (b)(6), 2019.As reported by physician the patient was in poor condition, cause of death cpr in icu after very bad prognoses in cath lab.Additional information has been requested.
Additional Manufacturer Narrative
The following sections were updated in follow-up 1: b4, g4, g7, h2, h6 and h10: the device was used for treatment.The device was not returned for analysis, therefore, the clinical observation could not be confirmed.Multiple attempts were made to obtain the information regarding device location however, no information is available.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.As per abiomed introducer sheath in-process and final inspection procedure, the devices in this lot were inspected as follows: 9.2.2 visual inspection: using 10x magnification, verify the tip is round, no flash protruding greater than 0.4 mm (0.016") and no flash with width (around circumference) greater than 0.7 mm (0.028"), no splitting, cracks or other damages.Slight discoloration from tipping process is acceptable.Verify proper tip shape according to drawing.Per section 12.2, visual inspection, with naked eye at a distance of 12" to 18", verify the assembled sheath matches the drawing.Ensure parts are free of kinks, cracks, splits, sinks, excessive flash, loose/embedded fm, or any other damages.The instructions for use (ifu) informs the user: never advance or withdraw guidewire or sheath when resistance is met.Determine cause by fluoroscopy and take remedial action.When injecting or aspirating through the sheath, use the sideport only.Avoid subjecting the device to unusual stresses.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 and the risk remains acceptable.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 34683
• MDR Report Key: 9586194
• Report Number: 1035166-2020-00004
• Device Sequence Number: 3674502
• Product Code: DYB
• UDI-Device Identifier: 00885672009748
• UDI-Public: 00885672009748
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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: 11/01/2022
• Device Model Number: 0052-3000
• Device Catalogue Number: 0052-3000
• Device Lot Number: C1-17774
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 120