MAUDE Adverse Event Report: OSCOR INC. SAFESHEATH II; SAFESHEATH® II

Model Number	SS8
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation is still in progress, follow up report will be submitted if we find any further additional information.
Event or Problem Description
It was reported during lead insertion in a icd placement physician attempted to remove the sheath and the on side tore off halfway while still in the patient.Physician had difficulty in removing remainder of the sheath.The event did not involve medication or other substance.No harm was caused to patient.No additional information is available.No adverse event reported.
Additional Manufacturer Narrative
The device was not returned for analysis.The device was used for treatment.Attempts were made to obtained the device.However, as of today the device was not returned for analysis.Therefore, the clinical observation could not be confirmed.The investigation was focused on a review of product documentation.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Per procedure adelante-s introducer sheath in process and final inspection: break and peel test: using samples from fit check as described procedure, manually break the sheath and hub and verify that the seal splits easily without extreme elongation.Also verify that the split cap and seal remain secure and do not break free or loosen from the sheath hub.Manually peel the sheath and verify the sheath peels easily along the sheath body and tip.Per ifu: sharply snap the tabs of valve housing in a plane perpendicular to the long axis of the sheath to split the valve and peel sheath apart while withdrawing from the vessel.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.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: SAFESHEATH II
• Common Device Name: SAFESHEATH® II
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• MDR Report Key: 11837613
• Report Number: 1035166-2021-00048
• Device Sequence Number: 2989912
• Product Code: DYB
• UDI-Device Identifier: 00802526532474
• UDI-Public: 00802526532474
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 10/07/2021

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: 08/01/2025
• Device Model Number: SS8
• Device Catalogue Number: SS8
• Device Lot Number: DP12240
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1