MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	26280
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.During unpacking of a 20x55/10fr uni plus 75cm wallstent, it was noted that the stent deployment tip was missing while the distal radiopaque marker band was still intact.Upon further inspection, the missing tip was not in the packing either.The procedure was completed with another wall stent.No patient complications were reported.
Event or Problem Description
It was reported that tip detachment occurred.During unpacking of a 20x55/10fr uni plus 75cm wallstent, it was noted that the stent deployment tip was missing while the distal radiopaque marker band was still intact.Upon further inspection, the missing tip was not in the packing either.The procedure was completed with another wallstent.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The blue outer was noted to be covering the tip upon device return.The investigator exposed the tip under blue outer by retracting the outer.A visual and tactile examination identified no issues with the tip of the device.The stent was returned fully constrained on the device and no issues were noted.A visual and tactile examination identified no issues.No other issues were identified during the product analysis.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9646749
• Report Number: 2134265-2020-00649
• Device Sequence Number: 14174065
• Product Code: JCT
• UDI-Device Identifier: 08714729204107
• UDI-Public: 08714729204107
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

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: 10/16/2021
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0024610411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1