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

Lot Number UNKNOWN

Device Problem Material Too Rigid or Stiff (1544)

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

Event Date 03/04/2021

Event Type  malfunction  

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.The lot number was not provided by the customer, therefore the device history records could not be reviewed, however, inspection procedures require any oscor product pass all in-process and qa final inspection before shipping to the customer.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 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 1035166-2021-00031 for dp-12235.Reference 1035166-2021-00032 for dp-12274.

• Brand Name: SAFESHEATH II
• Type of Device: INTRODUCER, CATHETER, PRODUCT CODE: DYB
• 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 1816
• Manufacturer Contact: doug myers ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 11588822
• MDR Text Key: 244723285
• Report Number: 1035166-2021-00033
• Device Sequence Number: 1
• Product Code: DYB
• 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: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2021
• 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