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

Model Number D141101

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 01/20/2022

Event Type  malfunction  

Event Description

It was reported that during a heliostar ee procedure the pullwire of the guidestar 13,5f sheath broke when trying to reach for the ripv.Pullwire snaps and guidestar couldn't be steered anymore.A new sheath of same thpe was used to successfully treat 3 out of 4 veins.During the same procedure the doctor was unable to isolate the lipv with the sheath and balloon, isolation was only transient and signals returned after several seconds.Several maneuvers and positions were used in order to isolate the vein but isolation was unsuccessful.The physician switched to thermocool catheter and was able to isolate the vein permanently with one shot near the lipv anterior carina.Patient was successfully treated without events but the procedure took at least one hour longer than expected.Pv isolation with balloon couldn't be achieved in 1 out of 4 veins.No additional information available.

Manufacturer Narrative

Conclusion not yet available, evaluation in process.A follow-up report will be submitted as soon as the investigation is complete.

Manufacturer Narrative

The following sections were updated in follow-up 1.B4, b5, d9, g3, g6, h2, h3, h6, h10.One 13.5f guidestar steerable introducer sheath was received without the dilator.There were no other accessories.Traces of blood were found on and inside the sheath.According to the event description summary, the physician heard the pull wire snap.The sheath was x-rayed and no breaks were found anywhere in the sheath and the hypo tubes were intact.Also, the sheath deflected normally as intended.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Returned device analysis revealed the sheath is within manufacturing specifications.It is unknown why the end user thought the pull wire broke because the sheath looked normal under x-ray and fully deflected as intended.According to the device history record, the introducer sheath passed all in-process and qa final inspection steps before shipping to the customer including visual, dimensional and mechanical testing.No manufacturing defects were found.Per manufacturing procedure (destino twist steerable guiding sheath handle assembly) sample size: 100%.Deflect the handle assembly using the deflection knob to assure that the completed product deflects as required.Per qa procedure (destino steerable guiding sheath in-process and final inspection) · deflection test is performed 100% by manufacturing personnel as per procedure and inspected by quality personnel.· for unidirectional models, verify the deflection knob is set to 0.Place the deflection section of the device on the applicable template and deflect the device until the curve falls within the applicable deflection template.Verify the device can deflect to 170° (nominal 180° - 10°) on half the template.Per ifu: preparing steerable sheath for insertion: · verify deflecting and straightening of the distal section of the steerable sheath using the handle of the sheath.Refer to deflecting and straightening the steerable sheath for instructions.General use of the steerable sheath: · do not force the steerable sheath assembly if significant resistance is encountered during the insertion or passage.If resistance is encountered, determine the cause and correct before continuing the procedure.Deflecting and straightening the steerable sheath: · twist the deflection collar slowly and carefully to deflect the distal tip.Caution: the sheath will deflect at the speed which the deflection collar is turned.Avoid rapid deflection that may cause vessel damage.· when the desired deflection point or site access is achieved, stop turning the deflection collar.No further follow-up is required.Based on the investigation a capa is not required for the pull wire break as findings did not identify a design, labeling or manufacturing non-conformity.However, capa p-1178 was opened for sheath deflection issue to investigate the root cause and implement corrective action to prevent recurrence of this issue.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

On 03/02/2022 the customer reported the procedure performed on (b)(6) 2022 was an external evaluation procedure.

• Brand Name: GUIDESTAR¿ STEERABLE GUIDING SHEATH
• 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 1816
• Manufacturer Contact: doug myers ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 13392691
• MDR Text Key: 284868248
• Report Number: 1035166-2022-00020
• 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
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: D141101
• Device Catalogue Number: D141101
• Device Lot Number: C8-19826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2020
• 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