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

Model Number	TG0704517
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
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
It was reported "aptus tourguide steerable sheath broke during use.Sheath separated from the handle.Packaging and sheath pieces saved at or control desk.Substitute item was used for the remainder of the procedure.At this time we do not know the lot number for this specific sample.".
Additional Manufacturer Narrative
The device was used in treatment.Several attempts were made to obtain this destino twist for analysis, but was not successful.Therefore, the clinical observation could not be confirmed, and the exact cause of the product issue cannot be determined.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.The following controls are in place to mitigate the reported product issue the destino twist is inspected per inspection 4d-51-028x-e (destino steerable guiding sheath in-process and final inspection).Visual inspection: with naked eyes, inspect outer hub for cracks, sinking, or unfilled areas and reject hubs that are not smooth because of those reasons inspect outer hub for excessive pinch or flash.Reject for excessive pinch or flash on hub.Any acceptable flash must be firmly attached.Verify the presence of chamfer and roundness of parts.Using the microscope 10x, check the inside of the hub and reject for flash and protruding sharp edges with the naked eye from 12-18", inspect molded hub for proper shape pull on the hub and the shaft verifying proper attachment without damaging shaft while pulling.Reject if the hub is loose from the shaft.Handle assembly verify the handle grip overmold has the correct logo per model specified on work order/traveler.Verify the two sides of the handle have minimal gaps.If the gap affects the function of the handle, reject the unit.Using the deflection inspection fixture, verify the centerline of the sheath meets the applicable deflection criteria.For destino twist models (ni- directional), reject the unit as "open deflection" if the deflection angle does not reach of 180° ± 10 in one direction.For destino twist models (uni-directional), reject the unit if the planarity measurement is greater than 8mm.Ifu : use the steerable sheath only with compatible transvenous devices.Use the appropriate size sheath for the size of the transvenous device being utilized.Consequences of using the steerable sheath with incompatible devices may include the inability to deliver the transvenous device or damage to the transvenous device during delivery.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.Caution: to ensure retention of the desired deflection position(s), avoid contact with the deflection collar that may cause the sheath to change deflection shape.Caution: when in the deflected position, the steerable guiding sheath should not be rotated while encountering resistance since that could severely damage the vessel, heart chamber, or anatomy of the patient 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.

• Brand Name: TOURGUIDE¿ STEERABLE 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 34683
• Manufacturer Contact: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279352511
• MDR Report Key: 15816376
• Report Number: 1035166-2022-00119
• Device Sequence Number: 12221853
• Product Code: DYB
• UDI-Device Identifier: 00850232006062
• UDI-Public: 00850232006062
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K120459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2023

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 Model Number: TG0704517
• Device Catalogue Number: TG0704517
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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