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

Model Number SS7

Device Problem Material Too Rigid or Stiff (1544)

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

Event Date 08/23/2021

Event Type  malfunction  

Event Description

It was reported that during implant the physician had difficulty peeling away the introducer and damaged the lead.The lead was attempted/not used and replaced with new lead.There was approximately a 30 minute delay in procedure.No patient complications have been reported as a result of this event.Per rep, the lot number is unavailable.The customer discarded the device.No additional information is available.

Manufacturer Narrative

The device was used for treatment.The device was discarded and not returned for analysis, therefore, the exact cause of the product issue cannot be determined and the clinical observation could not be confirmed.The lot number of this device was not provided, therefore neither a review of the device history record nor complaint history could be performed.Inspection procedures require any oscor product to pass all in-process and qa final inspections before shipping to the customer.However, the following controls are in place to mitigate the reported product issue.Per procedure adelante-s introducer sheath in process and final inspection, ensures sheaths are inspected for visual, dimensional, and peel functional compliance.Destructive testing sampling plan ansi z 1.4, special level 4, aql 0.40 reduced.Break and peel test: using samples from fit check, 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: 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.

• Brand Name: SAFESHEATH® II INTRODUCER SET
• 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: doug myers ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 12918123
• MDR Text Key: 284867859
• Report Number: 1035166-2021-00146
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 30891492002228
• UDI-Public: 30891492002228
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/02/2021

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
• Device Operator: Health Professional
• Device Model Number: SS7
• Device Catalogue Number: SS7
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 12/02/2021
• 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
• Patient Sex: Female