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

Model Number	SS8
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation is in progress, follow up report will be submitted if we find any further additional information.
Event or Problem Description
It was reported that when peeling the sheath crack was noticed.The sheath was cut open with small sharp scissors after it was torn off during peeling.The device issue resolved by carefully cutting the sheath.There was no surgical delay reported.There was no patient side effects reported.No additional information is available.
Additional Manufacturer Narrative
One 8f safesheath ii introducer sheath was returned from the customer without the dilator.There were no other accessories.Blood was observed on the sheath and inside the sideport tubing.Upon evaluation of the returned device, it was found that the sheath failed to peel apart properly along the score line.The hub and hemostatic valve broke apart normally as intended.The sheath peel almost immediately under the hub was starting to peel in a jagged/wavy manner and worsened until the peel terminated (sideport side) approximately 6.5cm down the sheath shaft.The peel jagged/wavy on the non-sideport side and the sheath was initially cut with scissors.Returned device analysis revealed the sheath failed to peel properly along the score line.The probable root cause for the peel failure could have been attributed to irregular and thick score lines.The break force data of the returned lot was reviewed and it was found that all samples were within manufacturing specification.According to the device history record, the introducer sheath passed all in-process and qa final inspection steps before shipping to the customer including visual, dimensional and mechanical testing.Per manufacturing procedure adelante, adelante-s and adelante-s2 sheath extrusion the appropriate extrusion tool is selected for the part to be extruded and is inspected prior to the extrusion run.The peel strength and critical dimensions are verified on every 100th extruded sheath as per procedure.Per qa procedure adelante-s introducer sheath in process and final inspection destructive testing - sampling plan ansi z 1.4, special level 4, aql 0.40 reduced 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 adelante safesheath ii: flush sheath with 5cc of saline immediately before peeling sheath away in order to minimize back bleeding.Withdraw sheath and valve over the lead or catheter and from the vessel, while keeping the lead in place.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.No further follow-up is required.No corrective or preventive action resulted after investigation of this event.Manufacturing and qa personnel were notified and awareness training was completed to prevent the recurrence of this issue.It was not found to be an systemic issue.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type.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: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• Manufacturer Contact: doug myers ; 3816 desoto blvd; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 12623158
• Report Number: 1035166-2021-00119
• Device Sequence Number: 17229550
• Product Code: DYB
• UDI-Device Identifier: 20802526532485
• UDI-Public: 20802526532485
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 03/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2020
• 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