MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID

Model Number 26606

Device Problems Difficult to Insert (1316); Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/25/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported that a foreign material was found on the device.The target lesion was located in the internal and common carotid arteries.An 8.0-29 carotid monorail stent was selected for use.However, a resistance was observed when the device was inserted into the y-connector.When the device was pulled back, a metal-like ring attached to the distal tip that appeared like a marker was confirmed.The procedure was then continued and completed with this device as the metal ring could be easily removed from the tip with a finger.No patient complications were reported.

Manufacturer Narrative

(e1) initial reporter city: (b)(6) device evaluated by mfr: a carotid device was returned for analysis.The device was returned with the stent deployed from the delivery system.The deployed stent was not returned with the device.A visual and tactile examination identified that the distal end of the t connector hub had come detached and moved along the delivery system.The investigator visually and microscopically examined the foreign material (fm) ring that was received and confirmed that the reported fm from the customer is part of the t connector hub that came detached.No other issues were identified during product analysis.

Event Description

It was reported that a foreign material was found on the device.The target lesion was located in the internal and common carotid arteries.An 8.0-29 carotid monorail stent was selected for use.However, a resistance was observed when the device was inserted into the y-connector.When the device was pulled back, a metal-like ring attached to the distal tip that appeared like a marker was confirmed.The procedure was then continued and completed with this device as the metal ring could be easily removed from the tip with a finger.No patient complications were reported.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• 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: 13871625
• MDR Text Key: 287819998
• Report Number: 2134265-2022-02455
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26606
• Device Catalogue Number: 26606
• Device Lot Number: 0028736321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2022
• 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