MAUDE Adverse Event Report: OSCOR INC 9F SAFESHEATH II; INTRODUCER, CATHETER

Model Number	SS9
Medical Device Problem Code	Aspiration Issue (2883)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Cardiomyopathy (1764)
Date of Event	01/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint is part of internal retrospective review of complaints received from march 2014 to march 2016, conducted by oscor as a result of process improvements made to the complaint system to ensure proper medical device reporting is maintained.As part of the detailed review, this event has been determined to be reportable.This initial mdr is being submitted to meet our requirements of reporting.A follow-up will be submitted as soon as the investigation is complete.
Event or Problem Description
It was reported that during implant, the sheath was positioned in the left subclavian vein.The physician observed air bubbles in the flush line and syringe when aspirating following sheath placement.It was noted that withdrawing the sheath approximately one centimeter prevented this during aspiration.Another sheath was attempted, however air bubbles were again observed during aspiration.A new sheath was used to complete implantation.No patient complications have been reported as a result of this event.Patient has history of dilated cardiomyopathy.No clinical actions required to the patient due to this event.Patient under planned general anaesthetic during procedure.Anaesthetist happy with ventilation during this event.New information received march 31, 2016: could you please provide the following information: did the surgeon flush the line to remove all air prior to use of the device? yes, this is done with every sheath (both haemostatic and non-haemostatic).Is it known if the 3-way stop cock was not in the correct (closed) position when the surgeon observed air bubbles in the flush line? implanting physician confirmed the 3-way stopcock was in the correct position as soon as the first bubbles were seen as part of her normal practice.
Additional Manufacturer Narrative
Returned device analysis reveals one 9f safesheath introducer within manufacturing specifications.According to the report, the physician observed air bubbles in the flush line and syringe when aspirating following sheath placement.Returned product evaluation revealed that the helical cuts in the hemostasis valve looked distorted and fatigued.It is unknown if another device was used in conjunction with the sheath.It is also unknown how the insertion was performed which created mechanical damage to the hemostasis valve.The product did not ship in this condition.The introducer sheath passed all in-process and qa final inspection steps before shipping to the customer including visual and dimensional inspection of the hemostasis valve, leak testing, and occlusion testing.The potential causes of air embolism include: physician does not remove all air before flushing, side port assembly fails during aspiration.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 the same (low).A review of the quality assurance procedure (adelante-s introducer sheath in process and final inspections) 100% inspection: perform a leak test on all adelante-s model sheath assemblies.Attach and lock 10 cc luer lock syringe to the activated valve/stopcock on the sideport.Push and pull the plunger of the syringe completely out all at once to confirm air flow through the sideport valve and tube.If there is an obstruction/blockage, it will be difficult to operate the plunger on the syringe.Even a partial obstruction will be felt by the operator.If any type of blockage or obstruction in the introducer sheath assembly is found, the item should be rejected and the appropriate supervisor should be alerted immediately.The safesheath ii instructions for use (ifu) provides these 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.Indwelling introducer sheaths should be internally supported by a catheter, electrode, or dilator.Dilators, catheters, and pacing leads should be removed slowly from the sheath.Rapid removal may damage the valve members resulting in blood flow through the valve.Never advance or withdraw guide wire or sheath when resistance is met.Aspirate all air from the sheath valve assembly by using a syringe connected to the side port.Flush the introducer through the side port.If the introducer is to remain in place during lead positioning and testing, flushing the introducer via the side port periodically with saline is advised.Summary of final analysis: returned device analysis reveals one 9f safesheath introducer within manufacturing specifications.According to the report, the physician observed air bubbles in the flush line and syringe when aspirating following sheath placement.The introducer sheath passed all in-process and qa final inspection steps before shipping to the customer including visual and dimensional inspection of the hemostasis valve, leak testing, and occlusion testing.

• Brand Name: 9F SAFESHEATH II
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd; palm harbor FL 34683 1816
• MDR Report Key: 6301921
• Report Number: 1035166-2017-00015
• Device Sequence Number: 537423
• Product Code: DYB
• UDI-Device Identifier: 30891492002259
• UDI-Public: 30891492002259
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K122084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2017

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: Physician
• Device Expiration Date: 06/01/2020
• Device Model Number: SS9
• Device Catalogue Number: SS9
• Device Lot Number: DP03385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/01/2016
• Supplement Date Received by Manufacturer: 03/01/2016
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR