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

Model Number H965SCH647080

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the stent delivery system got stuck on the wire.The target lesion was located in the carotid artery.During advancement of the 8.0-29 carotid wallstent over a non bsc guidewire, resistance was felt and the stent system got stuck while still outside of the patient.It was not possible to get the wire out of the stent system.A new device was used to complete the procedure.No further complications were reported and the patient status is stable.

Manufacturer Narrative

Device evaluated by manufacturer: a visual examination identified the stent fully mounted onto the delivery system.During the product analysis a 0.014¿ guidewire was inserted through this device without issue.The guidewire involved in the complaint was not returned for analysis.A visual and tactile examination found no kinks or other damage along the length of the catheter.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 root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported the stent delivery system got stuck on the wire.The target lesion was located in the carotid artery.During advancement of the 8.0-29 carotid wallstent over a non bsc guidewire, resistance was felt and the stent system got stuck while still outside of the patient.It was not possible to get the wire out of the stent system.A new device was used to complete the procedure.No further complications were reported and the patient status is stable.

• Brand Name: CAROTID WALLSTENT¿
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5148446
• MDR Text Key: 28218253
• Report Number: 2134265-2015-07055
• 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: Followup
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• Device Model Number: H965SCH647080
• Device Catalogue Number: SCH-64708
• Device Lot Number: 18143516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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