MAUDE Adverse Event Report: OSCOR INC. ANGIODYNAMICS SAFESHEATH ULTRA LITE; INTRODUCER, CATHETER, PRODUCT CODE: DYB

Model Number	VI7
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
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.
Event or Problem Description
During the procedure, the sheath broke into pieces when the catheter was advanced through the sheath.The wing of the sheath remained intact and the orange and clear part of the introducer broke into 2 to 4 pieces.This required the physician to carefully remove all the pieces to ensure none are left inside of the patient.The procedure was completed successfully and the patient did not experience any adverse effects or require medical intervention.Procedure was completed with another introducer.No additional information available.
Additional Manufacturer Narrative
The following sections were updated in follow-up 2.B4, d1, d4, g3, g6, h2, h10, h11 correction: d1: corrected brand name to angiodynamics safesheath ultra lite correction: d4: corrected model & catalog number from v17 to vi7 (should be roman numeral's) 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.
Additional Manufacturer Narrative
The device was used for treatment.The device was not returned for analysis, therefore, the clinical observation could not be confirmed.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Per procedure (adelante-s introducer sheath in process and final inspection) overmolded sheath: visual inspection: verify hub to be smooth, no cracks, sinking or unfilled areas, and check for fm verify hub shape as per drawing.Check for excessive flash (maximum allowable limit is 0.75 mm2).Using 10x microscope, look down into hub for irregularities.Verify smooth transition between sheath and hub on inside of hub.Verify one of the score lines of the sheath is aligned with the break line of the hub (handle).Break and peel test: 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.Strength test: using samples from break and peel test, use force gauge to determine the strength of the introducer sheath hub and side tube joint by placing the broken and peeled sheath hub and side tube in opposing pull tester clamps.Pull at a rate of 20 in/min until joint completely separates.The peak force at separation shall be > 3.37 lbf (15n).Per ifu, angiodynamics ssu lite: withdraw sheath from the vessel.Then remove the sheath by sharply snapping 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 further follow-up is required.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: ANGIODYNAMICS SAFESHEATH ULTRA LITE
• Common Device Name: INTRODUCER, CATHETER, PRODUCT CODE: DYB
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor 34683 1816
• MDR Report Key: 11924302
• Report Number: 1035166-2021-00054
• Device Sequence Number: 948577
• Product Code: DYB
• UDI-Device Identifier: 25051684026267
• UDI-Public: 25051684026267
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K073100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2025
• Device Model Number: VI7
• Device Catalogue Number: VI7
• Device Lot Number: DP-12450
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 09/15/2021; 09/30/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 09/16/2021; 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1