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

Model Number H7493915010240

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Occlusion (1984)

Event Date 02/05/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that blood clot occurred.The target lesion was located in the moderately tortuous and non-calcified internal carotid artery.After a non-bsc guide wire was engaged to the distal lesion, pre-dilation was performed.Subsequently, a 10.0-24 carotid wallstent¿ was advanced but resistance was encountered.It was also noted that the movement of outer sheath was not smooth.The device was removed and it was found out that there was a presence of blood in the stent part.According to the physician, "coagulation may be due to the presence of blood since it took time to perform positioning", the procedure was completed with another of the same device.No patient complications were reported and no patient injury occurred.

• 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: 6368296
• MDR Text Key: 68747346
• Report Number: 2134265-2017-01456
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• 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: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2019
• Device Model Number: H7493915010240
• Device Catalogue Number: 39150-1024
• Device Lot Number: 19342859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2016
• 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
• Treatment: GUIDE CATHETER: OPTIMO9F; GUIDE WIRE: GUARDWIRE
• Patient Outcome(s): Other