MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SUPER SHEATH INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number	220
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device sterile seal was damaged.A 6f x 11cm.038 super sheath was selected for use.During preparation, it was noted that one of the products was not sealed when one of the boxes were opened.Also, when they went to open the product up, they noticed that the sterile seal was not intact.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that the device sterile seal was damaged.A 6f x 11cm.038 super sheath was selected for use.During preparation, it was noted that one of the products was not sealed when one of the boxes were opened.Also, when they went to open the product up, they noticed that the sterile seal was not intact.The procedure was completed with another of the same device.No patient complications were reported.The device was returned for analysis.The actual item was returned in the state that the product was put into the sterilization bag and the sterilization bag was opened.The adhesive mark was observed on the peeled-off part of the sterilization bag.Visual inspection and sticker bag seal inspection after packaging of related materials revealed that all products passed the inspection as the seal of the opening of the sterilization bag of the product had been already sealed when it was delivered from our supplier.

• Brand Name: SUPER SHEATH INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8009891
• Report Number: 2134265-2018-62344
• Device Sequence Number: 13494869
• Product Code: DYB
• UDI-Device Identifier: 14543527181416
• UDI-Public: 14543527181416
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K060190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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: 04/30/2021
• Device Model Number: 220
• Device Catalogue Number: 220
• Device Lot Number: 18E21B6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1