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

Model Number	TG0855517
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
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.
Event or Problem Description
It was reported that the tourguide dilator was shorter than tourguide sheath so it couldn't be used.The patient received treatment, as the physician performed the procedure with another introducer.There were no patient symptoms or complications associated with this event.No adverse patient effects reported.The device was discarded.
Additional Manufacturer Narrative
Device was used in treatment.The device was not returned for analysis (device discarded).Customer provided a picture that appears dilator is shorter, however it cannot be confirmed without device.Manufacturing and qa departments were notified of complaint.A mix-up could have potentially occurred in the packaging process.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.However, following controls are in place to mitigate the reported product issue.Per area clearance procedure: · area clearance must be performed before each new batch/lot of product to be processed and at the beginning of each shift.· verify that the area is free of any materials that will not be used for the specific process.Including but not limited to all tables, bins, machines, tools, carts and/or others areas that could have remaining materials.Per qa destino dilator in-process and final inspection procedure sample size: inspect 100% first 5 and last 5 properly printed dilators.· using 10x microscope, verify printing is positioned correctly according to drawing and is legible.There should be no fm, smudges, missing numbers/letters or discoloration.Sample size: inspect 100% first 5 and last 5 properly tipped dilators.· measure length of dilator according to proper the drawing.Per manufacturing destino steerable guiding sheath and dilator packaging procedure: · clear the packaging area from the items not used in the packaging process.Work on one model length and curve of a product at a time.· prepare: product, bill of materials, work order, labels, destino packaging trays, dilators, the destino holding straps 1 & 2 and the tyvek pouches.Check the quantity of product to be packaged against work order.Verify the contents to be packaged match the bom.Verify quantity against the work order/traveler.Verify lot on the inner tray label.Instructions for use (ifu) is provided with this product.Based on the investigation, a capa is not required.Manufacturing and qa personnel were notified of complaint to prevent the reoccurrence of this issue.In addition, there was no new failure mode identified and the risk remains low.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 isbased 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: doug myers ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 12238984
• Report Number: 1035166-2021-00083
• Device Sequence Number: 5097761
• Product Code: DYB
• UDI-Device Identifier: 00850232006116
• UDI-Public: 00850232006116
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021

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: 08/01/2023
• Device Model Number: TG0855517
• Device Catalogue Number: TG0855517
• Device Lot Number: C8-20262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2020
• 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