MAUDE Adverse Event Report: OSCOR INC. INTRODUCER KIT FOR IMPELLA®; INTRODUCER, CATHETER

Model Number	0052-3006
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was provided for evaluation.Procedure was completed successfully with another device.There was no medical intervention, no additional surgery, and no procedure delay.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Without the return of the actual device in question for evaluation, oscor inc.Is unable to determine the exact cause for this incident.At this time, it is not possible to assign a definitive root cause for the event as reported.The complaint is non-verifiable as the product was not returned for evaluation.In conclusion, based on the information available at this time it cannot be confirmed that the product failed to meet requirements.The event will be re-evaluated if the device is returned for evaluation or 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.
Event or Problem Description
Patient's condition when presented to the physician was cardiomyopathy; patient is a 74-year-old, white female.During the procedure when the physician was inserting the introducer into the 8mm graft; the sheath started leaking, and it was found that the tip was split.The device was not used in a tortuous path when event occurred.The clinical representative does not know the brand name, model or lot number of the second introducer that was used to successfully complete the procedure.There was no medical intervention, no additional surgery, and no procedure delay.Additional devices used during the procedure are an impella 5.5 with smartassist s2 set, us (1000100) lot number 2025547602, serial number (b)(6).No patient injury reported.The device is not available for evaluation.

• Brand Name: INTRODUCER KIT FOR IMPELLA®
• 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: ronnie greco ; 4875 palm harbor blvd.; palm harbor 34683 ; 7279372511
• MDR Report Key: 20556574
• Report Number: 1035166-2024-00119
• Device Sequence Number: 18387286
• Product Code: DYB
• UDI-Device Identifier: 00885672009755
• UDI-Public: 00885672009755
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K122084
• 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
• Report Date (Section B): 10/29/2024

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 Expiration Date: 05/01/2024
• Device Model Number: 0052-3006
• Device Catalogue Number: 0052-3006
• Device Lot Number: DOR9061174
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2024
• 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: 74 YR
• Patient Sex: Female
• Patient Race: White