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

Model Number	0052-3021
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Death (1802)
Date of Event	07/03/2020
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 that on (b)(6) 2020, there was a 23 fr introducer sheath that cracked during a post cardiac-cardiogenic shock (pccs) right ventricle (rv) failure procedure.The user was placing the sheath when the rp sheath valve bleeding with insertion over stiff wire occurred.There was a procedure delay around 5 minutes.The patient expired days later, however, not related to the sheath issue.
Additional Manufacturer Narrative
The following sections were updated in follow-up.B4, b5, g3, g6, h1, h2, h6, h10.The device was used for treatment.The device was explanted and discarded, therefore the clinical observation could not be confirmed.The investigation will focus on a review of product documentation.As per procedure (abiomed introducer sheath in-process and final inspection), 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.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.Perform leak test per procedure.The leak test is performed by qa on 100% of the sheaths.Per 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.Aspiration and saline flushing of the sheath, dilator, and valve should be performed to help minimize the potential for air embolism and clot formation.Infusion through the sideport can be done only after all air is removed from the unit.Indwelling introducer sheaths should be internally supported by a catheter, lead, or dilator.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.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.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.
Event or Problem Description
It was reported that the patient lost about 20 cc of blood.

• Brand Name: ABIOMED INTRODUCER KIT FOR IMPELLA
• Common Device Name: INTRODUCER, CATHETER, PRODUCT CODE: DYB
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor, fl
• MDR Report Key: 10331773
• Report Number: 1035166-2020-00043
• Device Sequence Number: 935985
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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: 06/01/2021
• Device Model Number: 0052-3021
• Device Catalogue Number: 0052-3021
• Device Lot Number: C1-14301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR