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

Model Number	SS9
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
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 stated the event occurred intraoperatively.Sheath failed to split properly.The diaphragm remains intact after breaking the sheath apart.The doctor had to use another instrument to free the lead from the sheath.Successful (product remains implanted/procedure completed).No adverse event reported.
Additional Manufacturer Narrative
One 6f safesheath ii introducer sheath was returned under rma#: 1202100041 without the dilator.There were no other accessories.Traces of blood were found on and inside the sheath.According to the event description summary, the physician had to cut the hemostatic valve to free the lead from the sheath.Upon receipt of the product, the sheath was already peeled apart, and the hemostatic valve did not break in half as intended.This most likely occurred because the hemostatic valve wasn't slit sufficiently enough to break apart as intended.Per manufacturing procedure (introducer set, silicone seal slitting) once the cutting cycle is complete, the part will be placed on the machine tray.Remove the seal from the tray and perform a visual inspection using a 10x microscope.Finished center helix cut - verify the helix cut is complete and the seal was severed completely by checking for helix cut on the top and bottom of seal.Additional inspection for split seals: if the work order is for split seals prior to providing qa with the 5 samples, visually inspect and pull test the first 3 seals per section 7.4 seal pull test.If the pull tests are within specification, continue to run the first 5 samples for qa acceptance, visually inspect and submit to qa.Production may continue and seals may continue to be manufactured while pending the completion of the qa inspection.Partial cut - if the seal has a partial cut, ensure the cut did not cut through the full width of the seal (blade did not sever the membrane).Per qa procedure (adelante s2s introducer sheath in-process and final inspection) destructive testing: sampling plan ansi z 1.4, special level 4, aql 0.40 reduced break and peel test · using samples from fit check as described in 13.3.1, 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.Per ifu: 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.Returned device analysis revealed hemostatic valve of the sheath did not break apart during use.The valve was not cut sufficiently enough to tear in half as intended.This occurred because valve was not sufficiently cut with the partial cut required to break the hemostatic valve in half.Since the valve wasn't sufficiently cut, it allowed the outer part of the valve to break and slip out from under the hub/hubcap assembly when the sheath was peeled apart by the end user.Manufacturing and qa personnel have been notified of this issue to raise awareness and were informed to pay close attention to this detail.Capa: 05374 was opened to investigate the root cause and implement corrective action to prevent recurrence of this issue.The corrective action (capa: 05374) was deemed effective 08/23/2024.According to the device history record, the introducer sheaths passed all in-process and qa final inspection steps before shipping to the customer including visual, dimensional, and mechanical testing.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.
Event or Problem Description
09/11/2024: device is still in (b)(6), it will take some time to receive the device.As soon as we received the device we will forward it.09/16/2024: no patient harm reported.Provided patient identifiers.Procedure reported as new rv icd lead implant/ insertion.Minor procedure delay reported.Intervention reported as: the surgeon simply had to use scissors to cut away the offending portion of the sheath that failed to split.

• Brand Name: SAFESHEATH® II
• 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: ronnie greco ; 4875 palm harbor blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 20145077
• Report Number: 1035166-2024-00097
• Device Sequence Number: 14515204
• Product Code: DYB
• UDI-Device Identifier: 30891492002259
• UDI-Public: 30891492002259
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/25/2024

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: SS9
• Device Catalogue Number: SS9
• Device Lot Number: DP19667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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 Age: 67 YR
• Patient Sex: Female