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

Model Number	DCR1007317
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 59 year old male, weighing 69 kilograms underwent a stent percutaneous transluminal angioplasty (pta) of the arteria mesenterica superior (ams) procedure, using transfemoral access.After trying to insert the stent (vbx gore viabahn 8-59), the curve of sheath could not be deflected anymore.The doctor exchanged the steerable sheath, using another dst0707517 model and successfully completed the procedure.No extended hospitalization or additional surgical intervention was required, however, there was a 30 minute delay in the procedure.The patient is fine and no adverse patient effects were reported.
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up will be submitted as soon as the investigation is complete.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.
Additional Manufacturer Narrative
One 10f destino reach was received with the dilator.There were not others accessories.Blood was found on and inside of the sheath and dilator.According to the event description summary, the tip of the sheath did not deflect.Upon evaluation of the returned unit, it was found that the sheath would not deflect in either direction when the deflection collar was rotated.The sheath was x-rayed.It was found that the pull wires were detached from anchor ring.Also was verified that the anchor ring dislodged from its original intended position.Finally, a kink was observed near the tip.Returned device analysis revealed the sheath did not deflect in either direction when the deflection collar was rotated.An x-ray showed that both pull wires were broken.This leads to no deflection that kinks the deflection section area.This can be related to insufficient laser welding during the pullwire assembly operation.The sheaths are tested for deflection during in-process 100% inspection performed by manufacturing and additional aql sampling inspection by qa before shipping to the customer.Based upon investigation, no corrective or preventive action resulted after investigation of this event.Also, there are 100% pull testing controls to segregate any insufficient welding of the pull wire.According to the device history record, the introducer sheath passed all in-process and qa final inspection steps before shipping to the customer including visual, dimensional and mechanical testing.Per qa procedure (destino steerable guiding sheath in-process and final inspection) deflection test: perform deflection test according to procedure.The deflection test is performed by manufacturing personnel at 100% and inspected by quality assurance personnel through aql as established.Using the deflection inspection fixture, verify the centerline of the sheath meets the applicable deflection criteria.Before to starting to deflect the unit please ensure that the distal tip of the sheath is aligned with the distal engraved line of the template.For bidirectional destino, the deflection should be minimum 170° (nominal 180° - 10°) in the both (opposing) direction form the straight position of the sheath distal tip.The instructions for use (ifu) informs the user: the deflection mechanism is controlled by operator manipulation of the rotating collar handle.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.Do not deflect the sheath with dilator or with the device inserted.Based on investigation, no corrective or preventive action resulted after investigation of this event.Manufacturing and qa personnel were notified and awareness training was completed to prevent the recurrence of this issue.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 REACH 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: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 14828124
• Report Number: 1035166-2022-00076
• Device Sequence Number: 20053350
• Product Code: DYB
• UDI-Device Identifier: 00885672007621
• UDI-Public: 00885672007621
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151951
• 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): 12/05/2022

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: 03/01/2024
• Device Model Number: DCR1007317
• Device Catalogue Number: DCR1007317
• Device Lot Number: C8-21487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2021
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 69 KG