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	12/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft detachment occurred.During preparation of a 24x70/11fr 75cm wallstent uni; however, upon placing the device into the sheath, the shaft appear to be separated and would not deploy properly.The device was not used inside the patient and the procedure was completed with another of the same device.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that shaft detachment occurred.During preparation of a 24x70/11fr 75cm wallstent uni; however, upon placing the device into the sheath, the shaft appear to be separated and would not deploy properly.The device was not used inside the patient and the procedure was completed with another of the same device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the stent was returned fully mounted onto the delivery system.The investigator successfully deployed the stent, slight resistance was encountered due to the presence of solidified blood on the stent and delivery system.A visual and microscopic examination identified that some of the distal stent struts were damaged.No issues were noted with the stent that could have contributed to the damage identified.A visual and microscopic examination identified no damage or issues with the stent cups or stent holder of the returned device.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified no kinks or damage to the shaft of the returned device.No other issues were identified during the product analysis.There was evidence that the device was used in a manner inconsistent with the labeled indications.This wallstent uni device was used within a venous setting as it was reported that the intended use was in the iliac vein.As per dfu, the indicated use of this wallstent endoprosthesis tracheobronchial is in the treatment of tracheobronchial strictures produced by malignant neoplasms.

• 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: 8209663
• Report Number: 2134265-2018-64679
• Device Sequence Number: 265095
• Product Code: JCT
• UDI-Device Identifier: 08714729204176
• UDI-Public: 08714729204176
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

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: 10/26/2019
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0021303464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1