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

Model Number	26280
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event - used 07/01/2019 since event date was approximately a month go.
Event or Problem Description
It was reported that stent inadvertent deployment occurred.A 18 x 40/10fr uni plus 75cm wallstent endoprosthesis stent was selected for use.However, during preparation, it was noted that stent was deployed on the back table.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Date of event: used (b)(6) 2019 since event date was approximately a month ago.Device evaluated by mfr.: the device was returned with the stent fully deployed.The stent was not returned for analysis.No damage or issues were identified with the stent cup or stent holder that could potentially have contributed to the complaint incident.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified multiple severe kinks along the entire shaft of the device.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent inadvertent deployment occurred.A 18x40/10fr uni plus 75cm wallstent endoprosthesis stent was selected for use.However, during preparation, it was noted that stent was deployed on the back table.The procedure was completed with a different device.No patient complications were reported.

• 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: 8894234
• Report Number: 2134265-2019-09698
• Device Sequence Number: 286610
• Product Code: JCT
• UDI-Device Identifier: 08714729204060
• UDI-Public: 08714729204060
• 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): 09/11/2019

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: 04/24/2020
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0022035491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1