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

Model Number	M004DS200
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was used in treatment.The device was not returned for analysis, therefore, the clinical observation could not be confirmed.The investigation will focus on a review of product documentation.The lot number was not provided by the customer, therefore the device history records could not be reviewed, however, inspection procedures require any oscor product pass all in-process and qa final inspection before shipping to the customer.However, following controls are in place to mitigate the reported product issue.Per qa procedure (destino steerable guiding sheath in-process and final inspection).Sample size: first 5 good shots and 5 last shots of the lot, inspect 100%.Using 10 x microscope, verify presence of two (2) flush holes 180º ± 3° apart at distal tip.Reject if device holes are required but not present or are incorrectly aligned.With naked eye, inspect outer hub for loose or embedded fm.With naked eyes, inspect outer hub for cracks, sinking, or unfilled areas and reject hubs that are not smooth because of those reasons.The instructions for use (ifu) direx steerable sheath to 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.When the desired deflection point or site access is achieved, turn the locking button clockwise into the locked position.Caution: to ensure retention of the desired deflection position(s), avoid contact with the "locking" mechanism that may cause the sheath to change deflection shape.Deflect the sheath only with the provided dilator inside or without any device inserted.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.
Event or Problem Description
It was reported that a direx steerable sheath was used in a procedure.However it was noted that during the procedure a unspecified sheath complication occurred during the procedure.It was further reported on 21jun2021 that during the case a sheath complication occurred while the patient was on the table; two of the sheaths ports were not able to flush.The third sheath was used.No known patient complications.No additional information available.
Additional Manufacturer Narrative
The following sections were updated in follow-up 1.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: DIREX¿ STEERABLE SHEATH
• Common Device Name: 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: 12421798
• Report Number: 1035166-2021-00092
• Device Sequence Number: 11856567
• Product Code: DYB
• UDI-Device Identifier: 08714729858928
• UDI-Public: 08714729858928
• 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): 11/23/2021

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 Model Number: M004DS200
• Device Catalogue Number: M004DS200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 11/23/2021
• 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