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

Model Number 0052-3006

Device Problem Fluid/Blood Leak (1250)

Patient Problems Cardiogenic Shock (2262); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

Conclusion not yet available, evaluation in process.A follow-up will be submitted as soon as the investigation is complete.

Event Description

Patient is suffering from post cardiotomy cardiogenic shock.It was reported there was a 23f introducer that was leaking between the sheath and graft.Sheath was flushed and prepped with dilator inserted into 10/30 vascutek graft and 2 graft locks attached.Leaking noted out of graft.There was a five minute delay in procedure to find replacement sheath and exchange into graft.Blood loss was reported, amount of blood loss is unknown.Procedure was completed with another sheath.No adverse patient effects reported.

Manufacturer Narrative

The device was used in treatment.One 23f abiomed axillary sheath was returned.Traces of blood was found inside and outside of the sheath.The returned sheath was observed using a vertex at higher magnification and no cracks, holes or gaps were found.The sheath score lines were observed to be prominent on the outer surface.The sheath was leak tested per iso 11070 standard and procedure for leak test.Sheath leak test results did not show any leakage through the sheath score lines or the valve.Further investigation revealed that wall thickness of the scoreline has been reduce to improve the peel strength.Reduced wall thickness of the scoreline could have made the sheath susceptible to collapsing when used with graft locks, and that could have caused leakage.However, all devices that have been evaluated have met the current dimensional, visual, and functional requirements in the 23f sheath product specification.Further investigation revealed that wall thickness of the scoreline has been reduce to improve the peel strength.Reduced wall thickness of the scoreline could have made the sheath susceptible to collapsing when used with graft locks, and that could have caused leakage.However, all devices that have been evaluated have met the current dimensional, visual, and functional requirements in the 23f sheath product specification.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Per operations procedure(s) adelante, adelante-s and adelante-s2 sheath extrusion appropriate extrusion tool is selected for the part to be extruded and is inspected prior to the extrusion run.Peel strength and critical dimensions are verified on every 100th extruded sheath as per procedure.Per abiomed introducer sheath in-process and final sample size: 100% inspection the sheath is inspected with a naked eye at a distance of 12" to 18" to ensure the sheath is free of kinks, cracks, splits, sinks and any other damages.Leak test is performed as per procedure.Abiomed instructions for use (ifu) is provided with the product.Based on the investigation, a capa was not required.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 isbased 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®
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer Contact: doug myers ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 12167863
• MDR Text Key: 264488676
• Report Number: 1035166-2021-00067
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00885672009755
• UDI-Public: 00885672009755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Model Number: 0052-3006
• Device Catalogue Number: 0052-3006
• Device Lot Number: PQOC11882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Race: White