MAUDE Adverse Event Report: Oscor Inc. Destino¿ Reach¿ Steerable Guiding Sheath; INTRODUCER, CATHETER

Model Number	DCR0856717
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The valve of the sheath was leaking from the beginning and allowed blood leakage, despite a 0.035" terumo guidewire being in place.Consequently, the position had to be abandoned, and the sheath was replaced with a new destino reach.Device valve leakage / blood leakage; patient experienced blood loss.Issue was identified during mid bevar procedure, during cannulation of the target vessel.Terumo 0.035" guidewire used in combination with the oscor product.The sheath was removed and replaced with another destino reach.There was an approximate 10-minute procedural delay.No patient harm reported, and no extended hospitalization 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.

• Brand Name: Destino¿ Reach¿ Steerable Guiding Sheath
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): Oscor Inc.; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer (Section G): Oscor Inc.; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer Contact: mohit malkani ; 4875 palm harbor blvd.; palm harbor, FL 34683 ; +1(727)937-2511
• MDR Report Key: 50053249
• Report Number: 1035166-2026-00060
• Device Sequence Number: 9626610
• Product Code: DYB
• UDI-Device Identifier: 00885672007553
• UDI-Public: 00885672007553
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DCR0856717
• Device Catalogue Number: DCR0856717
• Device Lot Number: S10431572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/09/2026
• Supplement Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown