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

Model Number	DST0856517
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up report 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.
Event or Problem Description
The customer reported that during a fenestrated endovascular aortic repair procedure at the first angulation of the sheath at the level of the truncus coeliacus, the physician stated that the sheath kinked, and it was no longer possible for him to pass with the wire.He finished the procedure successfully with increased effort without a steerable sheath.The customer reported approx.30-minute delay in the procedure.Submitted for administrative purposes.
Additional Manufacturer Narrative
One 8.5f destino twist was returned from the customer with the dilator.There were no other accessories.Blood was found on and inside the sheath and dilator.Note: one 7f destino twist from an unknown lot number was received in the same bag as the 8.5f twist.The customer stated that it was unknown why this sheath was returned.According to the event description summary, the sheath kinked, and it was no longer possible to pass with the wire.Upon evaluation of the returned product, it was found that there were two kinks in the sheath shaft approximately 1.0cm and 4.2cm from distal tip.The dilator passed fully and smoothly through the sheath.The device(s) (wires) that were used in the procedure were not returned for analysis, so an exact fit check could not be performed.A 0.038" guidewire (maximum recommended thickness) was used to perform a fit check through the dilator and passed fully and smoothly, all the way through.Per qa procedure (destino steerable guiding sheath in-process and final inspection) sample size 100%: using a 10x microscope, visually inspect shaft body for the following criteria: inspect for rejectable surface defects (dents, bumps, scratches, gouges).If the scratch is purely cosmetic and it cannot be felt when running a gloved hand over it (material is not removed), the product is acceptable.Inspect for cracks/voids.Rejectable criteria include defects located at transitions between reflowed shaft sections and void of material along shaft body.Inspect for wrinkles or kinks.Reject the unit if the shaft body is wrinkled or kinked.Per ifu: avoid subjecting the device to unusual stresses.Handle the steerable sheath with care at all times.Before removing the steerable sheath from packaging, straighten the distal section as much as possible to avoid damage during removal.Never advance, torque, or withdraw sheath when resistance is met.Determine cause by fluoroscopy and then take remedial action.An unsupported sheath (without an inserted device or dilator) may be susceptible to kinking during advancement or torsional manipulation.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.Returned device analysis revealed the sheath was within manufacturing specifications.The dilator passed fully and smoothly through the sheath and a guidewire passed fully and smoothly through the dilator.Potential causes of the kink could have been due to an unsupported sheath, excess torque of the handle during use or resistance once inserted into the patient's body.According to the dhrs, the sheath and dilator passed all in-process and qa final inspection steps before shipping to the customer including visual, dimensional and mechanical testing.The root cause cannot be determined.No manufacturing defects were found.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.; 4875 palm harbor blvd.; palm harbor 34683
• Manufacturer (Section G): OSCOR INC.; 4875 palm harbor blvd.; palm harbor 34683
• Manufacturer Contact: daniel naut ; 4875 palm harbor blvd.; palm harbor 34683 ; 7279372511
• MDR Report Key: 17908272
• Report Number: 1035166-2023-00111
• Device Sequence Number: 7635615
• Product Code: DYB
• UDI-Device Identifier: 00885672006549
• UDI-Public: 00885672006549
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/27/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2025
• Device Model Number: DST0856517
• Device Catalogue Number: DST0856517
• Device Lot Number: DP-17805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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