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

Model Number 26633

Device Problems Difficult to Advance (2920); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2021

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.A 07f 10 090 placehit wallstent was advanced for treatment.During the procedure, the nose cone of the stent was observed to be out of shape under x-ray and it was difficult to advance the whole shaft.The physician removed the whole device and the procedure was completed using another of same device.There were no patient complications and the patient's status was stable.

Event Description

It was reported that stent damage occurred.A 07f 10 090 placehit wallstent was advanced for treatment.During the procedure, the nose cone of the stent was observed to be out of shape under x-ray and it was difficult to advance the whole shaft.The physician removed the whole device and the procedure was completed using another of same device.There were no patient complications and the patient's status was stable.It was further reported that there was no damaged on the stent struts.The 80-90% stenosed target lesion was located in the biliary duct.

Manufacturer Narrative

Device evaluated by mfr.: a placehit wallstent device was returned for analysis.The device was returned with the stent in the correct position on the delivery system.A visual and tactile examination identified damaged to the tip of the device.A visual and tactile examination identified a shaft kink 20mm distal from the distal end of the t connector.This concludes the product analysis.

Manufacturer Narrative

B5: updated event description.Device evaluated by mfr.: a placehit wallstent device was returned for analysis.The device was returned with the stent in the correct position on the delivery system.A visual and tactile examination identified damaged to the tip of the device.A visual and tactile examination identified a shaft kink 20mm distal from the distal end of the t connector.This concludes the product analysis.

Event Description

It was reported that stent damage occurred.A 07f 10 090 placehit wallstent was advanced for treatment.During the procedure, the nose cone of the stent was observed to be out of shape under x-ray and it was difficult to advance the whole shaft.The physician removed the whole device and the procedure was completed using another of same device.There were no patient complications and the patient's status was stable.It was further reported that there was no damaged on the stent struts.The 80-90% stenosed target lesion was located in the biliary duct.It was further reported that there was no contact with any other device until the stent was loaded onto the guidewire, then inserted into the sheath.After which the device was difficult to advance over the guide wire and it was removed.

• Brand Name: PLACEHIT BILIARY WALLSTENT
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13196660
• MDR Text Key: 283490069
• Report Number: 2134265-2022-00075
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2022
• Device Model Number: 26633
• Device Catalogue Number: 26633
• Device Lot Number: 0026012766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 01/07/2022; 02/10/2022
• Supplement Dates FDA Received: 01/28/2022; 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1