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

Model Number	DST0655509
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Arteriosclerosis/ Atherosclerosis (4437)
Date of Event	07/22/2021
Type of Reportable Event	Serious Injury
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 a sma stent procedure was to be performed.They were able to gain access and cannulated the sma artery with the steerable sheath and contrast injection was performed.After measuring the anatomy and getting ready to place the stent they tried to perform a verification contrast injection and contrast began to leak from within the handle.The procedure was stopped.Patient was taken to or for additional open surgery.Patient loss 200 cc, however, no blood transfusion was required.Patient is alive, extended hospital stay was required after surgery.
Additional Manufacturer Narrative
The device was in use for treatment.The device was not returned for analysis, therefore, the exact cause of the product issue cannot be determined and the clinical observation could not be confirmed.However, following controls are in place to mitigate the reported product issue.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Per qa procedure destino steerable guiding sheath in-process and final inspection sample size: ansi z 1.4, gen level i, normal, aql 1.5 normal leak test: perform leak test according to procedures based on available leak tester.The leak test is performed by manufacturing personnel and is observed by quality assurance.Per destino twist instructions for use (ifu): the steerable sheath must be thoroughly flushed with either saline or heparinized saline and free of air prior to use to avoid air embolism to the patient.Wet the dilator shaft with sterile saline solution prior to insertion through the hemostatic valve.Note: any device/component inserted through the hemostatic valve of the sheath should be wet and placed through the center of the valve to prevent tearing of the seal and leakage.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: DESTINO¿ TWIST¿ 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 34683
• Manufacturer Contact: doug myers ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 12395075
• Report Number: 1035166-2021-00091
• Device Sequence Number: 14627535
• Product Code: DYB
• UDI-Device Identifier: 00885672004019
• UDI-Public: 00885672004019
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2024
• Device Model Number: DST0655509
• Device Catalogue Number: DST0655509
• Device Lot Number: DP-13177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 60 KG