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

Model Number	SS6
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was used for treatment.The device was not returned for analysis, therefore, the exact cause of the product issue cannot be determined and the clinical observation could not be confirmed.However, following controls are in place to mitigate the reported product issue.Per procedure (adelante-s introducer sheath in process and final inspection) qa performs inspection as per 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.Per ifu: 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.The event will be re-evaluated if additional information becomes available.
Event or Problem Description
It was reported that the physician attempted the use of several safesheath ii units - each one that he used did not 'breakaway'.He had to use something else to cut it.Used 2 different lots of 7460 dp12235 & dp12274.The physician also had a 3rd one - couldn't find the packaging - was already in the trash and case was for a competitor's device.Reference 1035166-2021-00032 for dp-12274.Reference 1035166-2021-00033 for unknown lot.

• Brand Name: SAFESHEATH II
• Common Device Name: INTRODUCER, CATHETER, PRODUCT CODE: DYB
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 11588546
• Report Number: 1035166-2021-00031
• Device Sequence Number: 2955489
• Product Code: DYB
• UDI-Device Identifier: 20802526532447
• UDI-Public: 20802526532447
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122084
• 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
• Report Date (Section B): 03/30/2021

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: 09/01/2025
• Device Model Number: SS6
• Device Catalogue Number: SS6
• Device Lot Number: DP12235
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1