MAUDE Adverse Event Report: OSCOR INC SAFESHEATH® II; INTRODUCER, CATHETER

Model Number SS6

Device Problems Leak/Splash (1354); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Embolism (1829); No Consequences Or Impact To Patient (2199)

Event Date 06/23/2019

Event Type  Injury  

Manufacturer Narrative

The device used in treatment.One 6f safesheath ii peel away introducer sheath was returned from the customer with the dilator.There were no other accessories.Blood was found on and inside the sheath and dilator.Leak test was performed by injecting water through the stopcock/sideport tubing assembly with a syringe.Water leaked immediately and exited the proximal end of the sheath.The green split caps and sponge were removed to look for damages.It was found that there was no hemostatic valve present under the sponge.The probable cause for this missing valve is the operator error.This issue is identified to be isolated and is the first occurence known from past 2 years from the date of awareness.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Per procedure adelante - s introducer sheath in process and final inspections the inspector performs a visual inspection and verifies the assembled sheath matches specification, verifies the snap lock cap is placed properly onto sheath hub and free of cracks, verifies the snap lock cap is securely in place and the tabs are completely into the slots, verifies sponge center hold is aligned with seal center hold and clear of any cut out piece, and verifies sponge is fully lubricated and placed properly.The leak test is performed per procedure.Per procedure adelante-s sheath final assembly: leak test performed 100%.Leak test perform on all adelante-s model sheath assemblies per latest revision.Per ifu precautions: aspiration and saline flushing of the sheath, dilator, and valve should be performed to help minimize the potential for air embolism and clot formation.The hemostasis valve will reduce the loss of blood and the inadvertent aspiration of air through the sheath.Personal awareness training has been conducted to prevent the reoccurrence of this issue.Ncmr was initiated to further perform the complete investigation on the missing hemostasis valve.Based on investigation capa is not required.The event will be reevaluated if additional information becomes available.Oscor will continue to monitor this event type.

Event Description

On (b)(6) 2019 customer reported this event without any event description.Customer reported lot number only on (b)(6) 2019 customer reported "sheath had faulty valve.There was no impact to the patient, the patient is stable.The device was replaced with the same product.The issue was detected during the implant procedure, prior to pocket closure.Additional devices used are 7740/1007251 (rv lead) and 7740/1007280 (ra lead).Product is available for return." on (b)(6) 2019 customer reported " the valve is part of the introducer sheath 7460-667460300 that was utilized to gain access for lead placement.When dilator was removed from sheath air entered the sheath and went to the pulmonary artery.Introducer sheath was inserted in left subclavian.Procedure completed in standard fashion with no other issues outside of the air embolus." no other information is available and no other adverse event reported.

• Brand Name: SAFESHEATH® II
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd; palm harbor FL 34683 1816
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• Manufacturer Contact: doug myers ; 3816 desoto blvd; palm habror, FL 34683 ; 7279372511
• MDR Report Key: 9347721
• MDR Text Key: 167855152
• Report Number: 1035166-2019-00103
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 20802526532447
• UDI-Public: 20802526532447
• 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
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: SS6
• Device Catalogue Number: SS6
• Device Lot Number: DP09369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Date Manufacturer Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2018
• 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 Outcome(s): Life Threatening
• Patient Age: 95 YR
• Patient Weight: 68