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

Model Number 0052-3000

Device Problem Difficult to Advance (2920)

Patient Problems Rupture (2208); Blood Loss (2597)

Event Date 11/17/2018

Event Type  Injury  

Manufacturer Narrative

Our investigation is still in progress, follow up report will be submitted if we found any further additional information.

Event Description

It was reported that dilator lock mechanism on the sheath turns around its own axis and does not tighten when it's pushed back into the sheath.There was bleeding from groin.To stop bleeding physician advanced the introducer in femoral artery but it failed as dilator pushed out again.Additionally the femoral artery ruptured.Because hemodynamic support is urgently needed, puncture the contralateral groin and placed the impella catheter over a replacement introducer.Rupture of the femoral artery was closed by intervision radiologists & vascular surgeons via stent implantation in a femoral artery.Patient was presented to physician in cardiogenic shock.Patient died on (b)(6) 2018 as care was withdrawn by family due to question of neurological status from prolonged cpr.No additional information is available.

Event Description

Visual inspection of return device shows that sheath was split up, one of the scorelines approximately 11.5cm from the distal tip.

Manufacturer Narrative

Device used in treatment.One 14f abiomed introducer sheath was returned from the customer without the dilator.There were no other accessories.Visible blood was found on and inside the sheath.The sheath was split up one of the scorelines approximately 11.5cm from the distal tip.According to the complaint, the end user reported that the dilator lock mechanism on the sheath turns around its own axis and does not tighten.Upon evaluation of the returned product under a 10x microscope, it was found that the notches (locking mechanism) on the hub cap gouged/deformed.However, this hub was tested by the distributor prior to returning to oscor.The sheath was also split up one of the scorelines approximately 11.5cm from the distal tip and the circumference around the edge of the distal tip is deformed.The device was handled by the customer prior to shipping it back to oscor.It is unknown what kind of further damage was done to the hub cap locking mechanism by the customer by engaging a reference dilator through the sheath.No manufacturing defects were found.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Per procedure abiomed introducer sheath in-process and final inspections the following are inspected 100% unless otherwise stated: 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.With naked eye at a distance of 12" to 18", verify the sheath hub and split caps are free of excess silicone oil applied between the seals during assembly.Verify split caps are properly placed and secured onto sheath hub and free of cracks/damages or excessive adhesive.Vacuum leak test: perform pressure and vacuum leak test per procedure.Destructive testing: sampling plan ansi z 1.4, special level iv, aql 1.0 reduced (product used for destructive testing mustbe rejected and not included in the final production lot.Assembly fit check: coat a dilator with silicone oil med400, 1000 cp using a foam.Insert dilator into sheath, lock and unlock dilator hub lock nut for verification of proper fit.At a distance of 12-18, verify there are no gaps between the sheath tip and dilator.As per instructions for use ifu: 9.Insert vessel dilator into sheath and rotate the dilator cap over valve housing to secure the dilator onto sheath assembly.10.Thread the dilator/sheath assembly over the guidewire.11.Advance the dilator and sheath together with a twisting motion over the guidewire and into the vessel.Fluoroscopic observation may be advisable.Attaching a clamp or hemostat to the proximal end of the guidewire will prevent inadvertently advancing the guidewire entirely into the patient.12.Once assembly is fully introduced into the vascular system, separate the dilator cap from the sheath valve housing by rotating the dilator cap off the hub.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 14F INTRODUCER KIT FOR IMPELLA
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd; palm harbor FL 34683 1816
• MDR Report Key: 8160019
• MDR Text Key: 130208897
• Report Number: 1035166-2018-00104
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00813502011562
• UDI-Public: 00813502011562
• Combination Product (y/n): N
• PMA/PMN Number: K122084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Model Number: 0052-3000
• Device Catalogue Number: 0052-3000
• Device Lot Number: C1-14153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 03/19/2019
• Supplement Dates FDA Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention