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

Model Number SS95

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2022

Event Type  malfunction  

Event Description

It was reported that during the implant procedure the sheath did not tear away from the pacing lead had be to cut away from the lead.The sheath was safely removed from the lead.No patient complications have been reported as a result of this event.No additional information is available.

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.

Manufacturer Narrative

The device used in treatment.The device was not returned for analysis (discarded), therefore, the exact cause of the product issue cannot be determined and the clinical observation could not be confirmed.The lot number was not provided by the customer, therefore the device history records could not be reviewed, however, inspection procedures require any oscor product pass all in-process and qa final inspection before shipping to the customer.Per procedure for adelante-s introducer sheath in process and final inspection inspections: 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 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.The instructions for use (ifu) adelante safesheath ii, informs the user: 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.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
• Type of Device: 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: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 15047447
• MDR Text Key: 302065282
• Report Number: 1035166-2022-00084
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 30891492002266
• UDI-Public: 30891492002266
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SS95
• Device Catalogue Number: SS95
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1