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

Model Number	DCT1357125NM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation is still in progress, follow up report will be submitted if we find any further additional information.
Event or Problem Description
It was reported that sheath pull wire exposed while manipulating to get balloon out.No additional information is available.No patient complication is reported.
Additional Manufacturer Narrative
The device was used in treatment.One 13.5f destino twist steerable introducer sheath was received without the dilator.There were no other accessories.No visible blood was found on or inside the sheath.Upon returned product evaluation, it was found that the pull wire was broken and there was a kink.Further evaluation showed that the sheath was cut at approximately 1.3 cm from the sheath shaft distal tip.Upon returned product evaluation, it was found that the pull wire was broken and there was a kink.Further evaluation showed that the sheath was cut at approximately 1.3 cm from the sheath shaft distal tip.The sheath tip was found to be non-concentric.The hemostatic valve was normal and the anchor ring is intact.When id and od of the sheath shaft measured is within specification.X-ray revealed that proximal end of the hypotube was crimped.Returned device analysis revealed the sheath was manipulated by the customer as they cut the sheath at approximately 1.3 cm from the sheath distal tip hence, the root cause cannot be confirmed.Potential root cause for the pull wire break could have been due to the user trying to deflect the sheath when the kink had already occurred during use which have led the pull wire to break and to be exposed.Kinked could have occurred due to user subjecting sheath to the resistance.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: all of the following procedures are performed 100%: in process inspection liner inspection, pull wire alignment, marker band location, distal &proximal braid termination inspection.Using 10x microscope, verify pull wire is aligned properly with the grooves of the mandrel.Using a 10x microscope, verify braid is terminated and liner is not torn or nicked.In process inspection visual inspection after reflow, visual inspection of process mandrel after reflow, inspection for delamination.Inspect for wrinkles or kinks.Reject the unit if the shaft body is wrinkled or kinked.Assure that the pull wires are aligned properly with the hub.The pull wires should be aligned with the side port housing on the hub.For destino twist models (uni-directional), reject the unit as "open deflection" if the center line of the of the device deflection angle fails reach of 170° (nominal 180° - 10°) in one direction.Per qa procedure,destino pull wire assembly: test will be performed in the pull tester for the anchor ring.Confirm the pull tester anchor ring parameters are in: time 3.0 sec, pounds 15 and cycle 0/3 for destino bidirectional and for destino twist are in time 3.0 sec, pounds 8 and cycle 0/3.Place the subassembly of the anchor ring at the base of the pull tester; assure the ring is correctly inserted in the ring adapter of the fixture.Take one of the wires and place into the wire clamp and tighten the screw with a twisting motion, ensure that the wire is tight enough so that when operating, the wire will not release.Press start to activate the test fixture which will cycle three (3)times.Release the wire from the wire clamp and insert the 2nd wire only for destino bidirectional, repeating the steps above.If there's any detached, reject the part and contact your supervisor.Per ifu of destino twist: preparing steerable sheath for insertion:do not force the steerable sheath assembly if significant resistance is encountered during the insertion or passage.If resistance is encountered, determine the cause and correct before continuing the procedure.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.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
• MDR Report Key: 10046397
• Report Number: 1035166-2020-00032
• Device Sequence Number: 3357630
• Product Code: DYB
• UDI-Device Identifier: 00885672008819
• UDI-Public: 00885672008819
• Combination Product (Y/N): N
• 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): 10/07/2020

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: 07/01/2021
• Device Model Number: DCT1357125NM
• Device Catalogue Number: DCT1357125NM
• Device Lot Number: C8-14605
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1