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	03/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.During preparation of a 18x90/10fr uni plus 75cm wallstent endoprosthesis, it was noted that the white tip at the end of the catheter was missing.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that tip detachment occurred.During preparation of a 18x90/10fr uni plus 75cm wallstent endoprosthesis, it was noted that the white tip at the end of the catheter was missing.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned loaded on the customer's guide wire.A visual and tactile examination found the stainless-steel shaft of the device to be completely pulled from the t- connector exposing approximately 210mm of the inner shaft connected to it.This type of damage is consistent with excessive tensile force being applied to the device.A visual and tactile examination found the inner shaft of the device to be pulled into the blue outer shaft of the device for approximately 210mm.This type of damage is consistent with excessive tensile force being applied to the device.A visual and tactile examination identified no issues with the tip.The tip has no damage and is in the correct position on the device.After returning the stainless-steel shaft to its correct position in the t-connector, the investigator was able to successfully deploy the stent the no issues or resistance experienced.No damage or issues were identified with the deployed stent or the delivery system.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: 8514567
• Report Number: 2134265-2019-03850
• Device Sequence Number: 2758954
• Product Code: JCT
• UDI-Device Identifier: 08714729204084
• UDI-Public: 08714729204084
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/22/2019

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: 02/12/2021
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0023341612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1