MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CAROTID WALLSTENT¿; STENT, CAROTID

Model Number H965SCH647080

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: the device was returned with the stent fully mounted onto the delivery system.The device was returned still loaded onto the customer¿s guide wire.During product analysis, the investigator attempted to load the customer¿s guide wire and a boston scientific guidewire through this device, however severe resistance was encountered and the device could not be loaded onto the guide wire.A visual and microscopic examination noted two small perforations on the catheter of the device distal to the guide wire exit port; this type of damage is consistent with excessive force being applied to the device and the guide wire exiting out through the catheter.This was supported as the investigator observed the guide wire exiting out through the perforated catheter when they attempted to load the device onto the guide wire.During analysis, it was also noted that guide wire bypassed the guide wire exit port and continued down the inner shaft, this indicates that the inner shaft and outer sheath were not patent which may have prevented the guide wire from passing through the guide wire exit port.A visual and microscopic examination identified no damage or any issues with the stent or tip of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. the investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

Reportable based on device analysis completed on 12-nov-2017.It was reported that difficulties tracking over the wire were encountered.The target lesion was located in the internal carotid artery.After a filter wire was advanced, an 8.0-29 carotid wallstent¿ was advanced to treat the lesion.However, the device was unable to advance over the filter wire and the filter wire did not exit the monorail port.The procedure was completed with another 8.0-29 carotid wallstent¿.No patient complications were reported.However, returned device analysis revealed perforations on the catheter of the device distal to the guide wire exit port.

• Brand Name: CAROTID WALLSTENT¿
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7082447
• MDR Text Key: 93857109
• Report Number: 2134265-2017-11679
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2020
• Device Model Number: H965SCH647080
• Device Catalogue Number: SCH-64708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2017
• 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