MAUDE Adverse Event Report: OSCOR INC. GUIDESTAR¿ STEERABLE GUIDING SHEATH; INTRODUCER, CATHETER

Model Number D141101

Device Problem Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2022

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

It was reported error, introducing air repeatedly.There was no patient consequences reported.No additional information is available.

Manufacturer Narrative

The following sections were updated in follow-up 2: b4, g3, g6, h2, h10 and h11: correction to section h10 - deleted the following statement: complaint record will be updated once the device is returned and device evaluation is completed.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.

Manufacturer Narrative

The device was used in the treatment.The device was discarded and not returned for analysis; therefore, the exact cause of the product issue cannot be determined and the clinical observation could not be confirmed.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections before shipping to the customer.Complaint record will be updated once the device is returned and device evaluation is completed.The following controls are in place to mitigate the reported product issue.Per manufacturing procedure non-peelable sheath and final assembly: · seals are visually inspected before use.Seals are inspected to ensure the helical center cut is present before assembly.If the seal is not properly cut the seal is rejected.Appropriate manufacturing supervisor is notified before proceeding.· seal is placed carefully into the cap ensuring the cap is fully seated.If the seal has only one recessed ring ensure that the flat side of the seal is placed in the cap.Per qa procedure destino steerable guiding sheath in-process and final inspection: sample size: 100% using a 10x microscope, visually inspect shaft body for the following criteria - sample size 100% · inspect for rejectable surface defects (dents, bumps, scratches, gouges).· inspect for wrinkles or kinks.Reject the unit if the shaft body is wrinkled or kinked.· verify the device is free of kinks when deflected in one direction.The device is rejectable if a kink is observed.· leak test is performed according to procedure based on available leak tester.The leak test is performed by manufacturing and is observed by quality assurance personnel.The instructions for use (ifu) informs the user: the steerable sheath must be thoroughly flushed with either saline or heparinized saline and free of air prior to use to avoid air embolism to the patient.Aspiration and flushing of the sheath should be performed frequently to help minimize the potential for air embolism.For injecting or aspirating through the sheath, use the sideport only with stopcock.Prior to infusion, remove all air using the sideport.No further follow-up is required.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 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.

Event Description

Additional information received from the customer, they cannot find the product, it seems to have been discarded by mistake.

• Brand Name: GUIDESTAR¿ STEERABLE GUIDING SHEATH
• 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: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 13594011
• MDR Text Key: 290051506
• Report Number: 1035166-2022-00031
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00885672009496
• UDI-Public: 00885672009496
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: D141101
• Device Catalogue Number: D141101
• Device Lot Number: C8-19340
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2020
• 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