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

Model Number	D141101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up will be submitted as soon as the investigation is complete.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 or Problem Description
At the beginning of the procedure when introducing the lassostar nav into the hs catheter it felt some resistance which was relieved by moving the inflation knob in the handle.Then in the middle of the procedure, after 2 veins were ablated the sheath steering mechanism broke and it wasn't possible to curve it anymore.Lastly when removing catheters from the patient, the lassostar broke and came out without the "lasso" with the 10 electrodes.It was confirmed with x-ray the electrodes where inside the heliostar catheter.There was a 10-minute delay, while replacing the guidestar with a new one, and the procedure was successfully completed.There were no patient consequences.No additional information is available.
Additional Manufacturer Narrative
The device was used in treatment.Returned device analysis revealed the sheath was within manufacturing specifications.The sheath did not deflect when the deflection collar was rotated.An x-ray of the sheath showed that the pullwire was broken near the large hypotube.It is stated in the event description that resistance was encountered during the procedure.The instructions for use (ifu) states that if resistance is encountered, determine the cause and correct before continuing the procedure.It is unknown if the sheath was over torqued with the device inside causing the pullwire to break.The sheaths are tested for deflection in-process 100% before shipping to the customer.According to the dhr, the introducer sheath passed all in-process and qa final inspection steps before shipping to the customer including visual, dimensional and mechanical testing.The cause of the steering mechanism break is inconclusive.No manufacturing defects were found.Per procedure destino steerable guiding sheath in-process and final inspection deflection test: perform deflection test according to procedure.The deflection test is performed by manufacturing personnel at 100% and inspected by quality assurance personnel through aql as established.Using the deflection inspection fixture, verify the centerline of the sheath meets the applicable deflection criteria.Before to starting to deflect the unit please ensure that the distal tip of the sheath is aligned with the distal engraved line of the template.For unidirectional models, verify the deflection knob is set to 0.Place the deflection section of the device on the applicable template as shown in figures below 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.For destino twist models (uni-directional), reject the unit as "open deflection" if the center line of the of the device deflection angle fails reach of 170° (nominal 180° - 10°) in one direction.The instructions for use (ifu) informs the user: 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.No further follow-up is required.Based on the investigation, no corrective or preventive action resulted after investigation of this event.Additionally, the risk remains acceptable, and no new failure mode identified.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.

• Brand Name: GUIDESTAR¿ STEERABLE GUIDING SHEATH
• Common Device Name: 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 34681
• Manufacturer Contact: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34681 ; 7279372511
• MDR Report Key: 17241197
• Report Number: 1035166-2023-00068
• Device Sequence Number: 15177997
• Product Code: DYB
• UDI-Device Identifier: 00885672009496
• UDI-Public: 00885672009496
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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: Health Professional
• Device Expiration Date: 04/01/2024
• Device Model Number: D141101
• Device Catalogue Number: D141101
• Device Lot Number: C8-21828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown