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

Model Number	667464-300
Medical Device Problem Codes	Air Leak (1008); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.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
The complaint was that the introducers they were using during a couple of implant cases appeared to be leaking.Here is a summary from the complaint: the physician complaint that the sheaths we use seem to be leaking.After gaining access and putting a sheath through the puncture site, when attempting to flush the sheath, there are a lot of air bubbles that is aspirated as he draws back the sheath[?].As a result, there was air introduced into the patient's vessels as he advances the lead into the body.He is concerned as this puts patient at risk of embolism and hypotension.The following information received was received on february 8, 2018: event date: (b)(6) 2017.Reported region: (b)(6).Did the event involve a patient: yes.Age and sex of patient: male (b)(6) years old.What is the outcome of the patient: no adverse patient effects were reported.No impact to the patient/stable: there was no reported impact to the patient.If patient impact, please provide details: any reported adverse patient effects: no adverse patient effects were reported.Any extended hospitalization: none reported.It was reported the sheath was leaking, how was the product issue resolved: was another model of the same device used, or was there a different model and a different manufacturer's device used.If different model and manufacturer please provide this information including lot number/serial number: different sheath was used - (b)(4).What procedure or treatment was this device used in: no additional treatment/intervention was required.
Additional Manufacturer Narrative
The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.A complaint review of the reported lot found no additional reports involving this lot number.One adelante ii 9.5f safesheath introducer sheath was received with the dilator.The guidewire was not returned.There were no other accessories.Traces of blood were found on and inside the introducer sheath.The helical cuts in the hemostasis valve looked distorted and was not closed/shut.The distal tip of the dilator had sustained impact damage.Only one device was returned although the customer indicated this happened multiple times.One 9.5 f safesheath introducer and dilator were returned for investigation.The introducer and dilator both had slight tip damage (unrelated to the reported failure mode).A leak test was performed by injecting water through the stopcock with a syringe.No leakage was observed on the product, and water exited the tip of the sheath as intended.The distal tip of the sheath was blocked off and water was injected through the stopcock.Water exited through the hole in the hemostatic valve (as seen in image 1) as expected due to the damage in the valve on the returned product, but no leaks were observed elsewhere on the product.The dilator was placed through the product and water was injected through the stopcock.The water exited the sheath tip (traveling in the space between the sheath and dilator), and no leaks were observed from the valve, hub, or side-port.Water was then injected through the dilator and it exited the dilator tip as expected with no leaks elsewhere.The device was held horizontally to simulate as if it were in an artery and water was injected through the stopcock (without the dilator inserted).Water leaked through the hemostatic valve and exited the tip of the sheath.The grey split caps, sponge, and hemostatic valve were removed.The hemostatic valve recovered to a closed position when it was removed from the product.The device was then re-assembled.The valve had a small pin-hole after reassembly, prior to inserting the dilator.The dilator was then placed through the center of the valve, and removed.After the dilator was removed, the valve had a large hole similar to the size that was observed when it was initially returned from the customer.The device was then re-assembled.The valve had a small pin-hole after reassembly, prior to inserting the dilator.The leak test was performed horizontally, and water leaked through the hemostatic valve along with exiting the tip of the sheath.Upon evaluation of the returned sheath, it appeared that the user did insert devices centrally through the hemostatic valve as intended.However, the valve was found to be open and was not fully closed causing leakage.This was replicated after disassembling and reassembling the valve, once the dilator was reinserted and removed from the device.This valve that did not fully close resulted in leakage.Returned device analysis reveals one 9.5 f safesheath introducer and dilator within manufacturing specifications.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.During the risk evaluation, it was determined the risk anlaysis did not contain a failure mode associated with this event.The risk analysis will be updated.The risk level of the new failure mode has been identified as medium.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.Per qa 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.Per qa procedure leak test - introducer with seal- electronic tester, leak test is performed.Per manufacturing procedure introducer set, silicone seal slitting, the operator visually inspects all the slit seals for defects 100% with a microscope.The instructions for use (ifu) informs the user under the warnings section, "infusion through the side port can be done only after all air is removed from the unit." under the precautions section, the ifu states, "aspiration and saline flushing of the sheath, dilator, and valve should be performed to help minimize the potential for air embolism and clot formation." "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 guide wire or sheath when resistance is met.Determine cause by fluoroscopy and take remedial action." 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: ADELANTE SAFESHEATH II
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 de soto blvd.; palm harbor FL 34683
• MDR Report Key: 7301605
• Report Number: 1035166-2018-00016
• Device Sequence Number: 1918003
• Product Code: DYB
• UDI-Device Identifier: 20802526532522
• UDI-Public: 20802526532522
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/15/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 03/01/2022
• Device Model Number: 667464-300
• Device Catalogue Number: 667464-300
• Device Lot Number: DP05692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 42 YR