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

Model Number SS7

Device Problem Material Too Rigid or Stiff (1544)

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

Event Date 08/28/2021

Event Type  malfunction  

Manufacturer Narrative

Our investigation is still in progress, follow up report will be submitted if we find any further additional information.

Event Description

It was reported that during implant of the pacing lead, the sheath did not split properly, leaving a small portion of the sheath attached to the pacing lead.One ear and small portion of the sheath barrel broke off before the sheath was split completely and removed the physician had to use a small kelly forceps to grasp the remaining part of the sheath and carefully manipulate the sheath barrel so it would split the rest of the way without damaging the pacing lead.The procedure was completed with no further issues. no patient complications have been reported as a result of this event.No additional information is available.

Manufacturer Narrative

One 7f safesheath without the dilator was returned for analysis.There were no traces of blood found on the sheath.The sheath was returned in 4 separate pieces.Upon returned product evaluation, it was observed that the sheath did not peel properly.The sheath hub and hemostatic valve broke normally.The sheath peel immediately under the hub was normal both on the side port side and the non side port side.The sheath started to peel jaggedly/wavy manner at 3cm and worsened at the peel termination at approximately 6cm on the non sideport side.Remaining sections of the side port side were cut using forceps as mentioned in the event description.Returned device analysis revealed the sheath did not 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.A personnel notification was sent to the manufacturing operators to notify them of this event.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections per delante, 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 per delante 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.A personnel notification was sent and manufacturing personnel were retrained to their procedure prevent further recurrence of this issue.No corrective or preventive action resulted after investigation of this event.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type.Per procedure 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 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 1816
• 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: 12689599
• MDR Text Key: 278149051
• Report Number: 1035166-2021-00124
• 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,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• 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: 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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