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

Model Number	DST0654509
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
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 when the scrub nurse received the destino twist sheath on her table, the lateral cannula fell down from the handle of the sheath.It seems the cannula was not connected to the handle.
Additional Manufacturer Narrative
One 6.5f destino twist steerable guiding sheath was received under rg24051/ca with the dilator.There were no other accessories.Traces of blood were found on and inside the sheath and dilator.According to the event description summary, the cannula was not connected to the handle before the procedure began.See customer provided photo above left.The sideport tubing was detached from the hub stem upon receipt of the product.Upon evaluation under a microscope, it was found that there was evidence of light adhesive residue on the sideport tubing and adhesive residue on the hub stem.Per manufacturing procedure (non-peelable sheath sideport assembly) apply one drop of the adhesive on the pellethane side tube at a distance of 2- 3mm from the end.Spread the adhesive around the od of the tube by rotating the tube 360° while applying the drop of adhesive.Repeat the step by placing a drop of glue approximately 6-7mm from the same end and spread the glue by rotating the tube while applying the adhesive around the od of the tube.Rotate the tube to ensure that the adhesive is applied all around the circumference of the tube uniformly.Fully insert the tube into the sheath hub sideport opening while rotating it 360°.Wipe away any excess adhesive sticking out of the sideport with a polywipe.After curing (undisturbed, for a minimum of 4 hours) test the joint of each part with a small tug, holding the tube in one hand and the stopcock in the other hand.Discard all parts that detach during the tug, do not attempt to cure parts again.Per qa procedure (destino steerable guiding sheath in-process and final inspection) sample size 100% using a 10x microscope, inspect sideport tube assembly for excessive glue at both joints.A bead of glue around the perimeter of the side port tube to hub joint is acceptable.Smeared glue on sideport assembly is not acceptable.Note: check both the sheath hub to sideport tube and stopcock to side port tube.Using a 10x microscope, check for loose and embedded fm and damages to hub, sheath, stopcock, and side tube.Check for fm in the stopcock.Manual tug test using a metric ruler at a distance of 5mm to 10mm, check the integrity of the bond gluing with firmness by gently pulling on both joints: sheath hub to sideport tube and stopcock to sideport tube.Per 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.The sheath sideport with stopcock can be used throughout the procedure to aspirate or deliver liquids.Returned device analysis confirmed detachment of the sideport tubing.This can happen if the curing time of 4 hours is not fully reached and/or the units are handled or moved around during that time.The manufacturing procedure establishes that the units must remain still until curing time is fully reached.This means that the procedure may not have been followed as established.Retraining was conducted with manufacturing personnel on the applicable procedure to prevent recurrence of this issue.In conclusion, based on the information available at this time it is confirmed that the product failed to meet requirements.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: 18837831
• Report Number: 1035166-2024-00014
• Device Sequence Number: 7486399
• Product Code: DYB
• UDI-Device Identifier: 00885672004002
• UDI-Public: 00885672004002
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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 Model Number: DST0654509
• Device Catalogue Number: DST0654509
• Device Lot Number: DP-21096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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