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

Model Number	DST0654509
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
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 during a embolisation, coil procedure the green hub has disconnected during the procedure, during the transition at the handling from white to gray (which with hemostasis valve and gray of the oscor inscription) blood pressed out during the whole procedure.The patient is well and was never at risk.The complaint was not reported to any authority.The procedure was finished with another destino twist.
Event or Problem Description
It was reported that during a embolisation, coil procedure the green hub disconnected during the procedure, during the transition at the handling from white to gray, blood pressed out during the entire procedure.There was no risk to the patient, therefore, the procedure was finished with another destino twist.
Additional Manufacturer Narrative
One 6.5f destino twist and dilator were returned.There was blood found inside and on both the sheath and dilator.Upon evaluation of the returned device, it was observed that the hub cap was detached from the sheath handle.Evidence of sufficient adhesive was found on the sheath hub and underneath the sheath hub cap.Sheath tip was observed to be round and normal.Sheath valve was observed to be normal with helical cuts.A possible cause of the sheath hub detachment could have been due to manipulation around the sheath hub with the ancillary devices used during procedure.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Returned device analysis revealed that the hub cap was detached.There was sufficient adhesive observed under the hub cap and on the handle where the hub cap is seated.Exact root cause for the hub cap detached could not be determined.However, a possible cause of the sheath hub cap detachment could have been due to manipulation around the sheath hub with the ancillary devices used during procedure.Dhr was reviewed and no manufacturing defects were found.Per procedure (destino steerable guiding sheath in-process and final inspection): cap and seal are inspected and the results are registered on the form.Sample size: ansi z 1.4, gen level i, normal, aql 1.5 normal leak test is performed according to procedure based on available leak tester.The leak test is performed by manufacturing personnel at 100% and is observed by quality assurance personnel.Per procedure (non-peelable sheath final assembly) - manufacturing procedure: glue is placed using a glue dispensing tip below the seal around the outer rim of the sheath hub.The bonded cap of appropriate color is seated properly over the hub and is secured with a sheath assembly fixture.The sheath is allowed to remain in the fixture for at least 2 minutes after securing the last sheath in the fixture.After it is removed from the fixture, ensure that there is no excess adhesive.After the fixture is removed, each sheath is laid flat on the table for a minimum of 15 minutes before proceeding.Sheath assemblies must remain undisturbed for a minimum of 15 minutes.Bonded caps are visually inspected after curing.Gap between the bonded cap and the hub should not exceed 0.020".Sheath should be free of damages and defects.Ifu: use the sideport, located at the handle, to inject contrast solution or flush the steerable sheath.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.Aspiration and flushing of the sheath should be performed frequently to help minimize the potential for air embolism.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.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, PRODUCT CODE: DYB
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor 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: 12434398
• Report Number: 1035166-2021-00089
• Device Sequence Number: 14331711
• Product Code: DYB
• UDI-Device Identifier: 00885672004002
• UDI-Public: 00885672004002
• Combination Product (Y/N): N
• Initial Reporter Country: WZ
• 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): 12/02/2021

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: 04/01/2024
• Device Model Number: DST0654509
• Device Catalogue Number: DST0654509
• Device Lot Number: DP-13156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 12/02/2021
• 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