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

Model Number 26280

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2018

Event Type  malfunction  

Event 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 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.

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
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8209663
• MDR Text Key: 131836271
• Report Number: 2134265-2018-64679
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 08714729204176
• UDI-Public: 08714729204176
• Combination Product (y/n): N
• PMA/PMN Number: K152842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1