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

Model Number	28211
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that device contamination occurred.A 10frx11cm super sheath introducer sheath was selected for use.Upon unpacking, it was noted that the primary packaging was open.The secondary packaging was sealed but the device was not used as it has lost its sterility.The procedure was completed with a different device.There were no patient complications were reported.
Event or Problem Description
It was reported that device contamination occurred.A 10frx11cm super sheath introducer sheath was selected for use.Upon unpacking, it was noted that the primary packaging was open.The secondary packaging was sealed but the device was not used as it has lost its sterility.The procedure was completed with a different device.There were no patient complications were reported.
Additional Manufacturer Narrative
E1: initial reporter facility name (b)(6).E1: initial reporter address 1- (b)(6).Device evaluated by manufacturer: the device was not returned for analysis.The actual item was not returned, but photos were provided.From an investigation of the provided photo, it was confirmed that the sealed part on the opposite side of the opening mouth of the sterile bag was open.An adhesive mark was observed on the part of the sterile bag where the seal was open.
Event or Problem Description
It was reported that device contamination occurred.A 10frx11cm super sheath introducer sheath was selected for use.Upon unpacking, it was noted that the primary packaging was open.The secondary packaging was sealed but the device was not used as it has lost its sterility.The procedure was completed with a different device.There were no patient complications were reported.
Additional Manufacturer Narrative
E1: initial reporter facility name - (b)(6).E1: initial reporter address 1- (b)(6).Device evaluated by manufacturer: the device was returned for analysis.One set of packaging with a sheath in it was returned.Actual returned product was investigated, and it was confirmed that the central part of the seal part on the opposite side of the opening mouth of the sterile bag was open.Seal marks were found on the part where the seal of the sterile bag was peeled off.It was also confirmed that the part where the seal remains was firmly welded.Welding peel strength of the part where the seal remains was measured, and it was confirmed that it was above the standard value.

• 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: 10749317
• Report Number: 2134265-2020-14857
• Device Sequence Number: 3060539
• Product Code: DYB
• UDI-Device Identifier: 14543527201916
• UDI-Public: 14543527201916
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2021

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: 01/31/2022
• Device Model Number: 28211
• Device Catalogue Number: 28211
• Device Lot Number: 19B07B1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 11/16/2020; 01/11/2021
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 11/30/2020; 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1