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

Model Number H965SCH647070

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id: 2134265-2017-06523.It was reported that removal difficulties were encountered.An 8.0-21 carotid wallstent and a 190cm filterwire ez were selected for use.Following deployment of the carotid wallstent, it was noted that the stent delivery system was impossible to remove as the catheter got stuck on the filter wire.Both devices were removed as unit.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned and analyzed.The stent had been deployed from the delivery device.The device was received with the customer¿s 0.014inch guidewire.Multiple kinks were noted along the length of the device.Solidified blood was observed within the guidewire lumen.During product analysis the investigator attempted to load the device onto both the customer¿s 0.014'' guidewire and a 0.014¿¿ boston scientific guidewire, however severe resistance was encountered and it was not possible load either guidewire through this device.A visual and tactile examination identified multiple kinks along the length of the shaft.This type of damage is consistent with excessive force being applied to the delivery system.Damage was also noted at the guidewire exit port.This may have been caused by the guidewire when resistance was encountered during removal.No issues were noted with the stent cups or stent holder 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 most probable root cause was unable to be determined.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-06523.It was reported that removal difficulties were encountered.An 8.0-21 carotid wallstent and a 190cm filterwire ez were selected for use.Following deployment of the carotid wallstent, it was noted that the stent delivery system was impossible to remove as the catheter got stuck on the filter wire.Both devices were removed as unit.

• 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: 6691112
• MDR Text Key: 79235107
• Report Number: 2134265-2017-06530
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2018
• Device Model Number: H965SCH647070
• Device Catalogue Number: SCH-64707
• Device Lot Number: 17638544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2015
• 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