MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTRO SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Event Description

It was reported that a wet film inside the sterile package was found.A wet film was noted inside the sterile packaging of an introducer sheath.The oily residue was seen inside the package near the device hub.When the package was opened, it was almost oily when felt.No patient involvement was reported.

• Brand Name: INTRO SHEATH
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): MEDIKIT COMPANY LIMITED; 13-2 yushima 1-chome; bunkyo-ku tokyo 113 ; JA 113
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10304625
• MDR Text Key: 200803411
• Report Number: 2134265-2020-09580
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2020
• 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