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 11/09/2021

Event Type  malfunction  

Event Description

It was reported during the implant procedure, the introducer sheath would not peel.The hcp had to use surgical scissors to peel the sheath.The device issue was resolved by cutting the sheath.No surgical delay or extended hospitalization was reported.There was no patient side effects reported.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.

Manufacturer Narrative

The following sections were updated in follow-up.B4,d9,g3,g6,h2,h6,h10.The device was used in treatment.One 7f safesheath introducer was returned from the customer without the dilator.There were traces of blood found on the sheath.Upon evaluation of the returned product, it was found that the sheath hub and hemostatic valve broke normally as intended.The sheath shaft peeled apart on the score lines normally for approximately 5cm, then started to peel apart in a jagged/wavy manner and then the sheath was cut with scissors for the last 4.5cm.Returned device analysis revealed the sheath did not peel apart properly all the way 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.A personnel notification was sent to the manufacturing operators to notify them of this event.Operations procedure(s) , adelante, adelante-s and adelante-s2 sheath extrusion · appropriate extrusion tool is selected for the part to be extruded and is inspected prior to the extrusion run.· peel strength and critical dimensions are verified on every 100th extruded sheath as per procedure.Adelante s2s introducer sheath in-process and final inspections, ansi z 1.4 sampling plan: special level 4, aql 0.40 reduced.· after the hub break test, manual peel test is performed to ensure that the sheath easily dislodges along the body of the sheath.· the sheath is visually inspected to verify one of the score lines of the sheath is aligned with the break line of the hub (handle) - sample size: first 5 good shots and 5 last shots.The instructions for use (ifu) 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 corrective or preventive action resulted after investigation of this event.An awareness training was conducted to prevent recurrence of this 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 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: 12956371
• MDR Text Key: 284868414
• Report Number: 1035166-2021-00150
• 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: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• 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
• Device Lot Number: DP13500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2021
• 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