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

Model Number 26605

Device Problems Entrapment of Device (1212); Failure to Advance (2524)

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

Event Date 10/05/2022

Event Type  malfunction  

Event Description

It was reported that entrapment on guidewire occurred.Vascular access was gained via the femoral artery.The 70% stenosed target lesion was located in the non tortuous and severely calcified venous sinus.A 8.0-36 carotid wallstent was selected for use.During the procedure, the device was unable to cross the lesion and became stuck on the 0.14 guidewire.Another of the same device was used to complete the procedure.There were no patient complications, and the patient status was stable.

Manufacturer Narrative

Device evaluated by mfr: a carotid device was received for analysis.During the product analysis, a boston scientific 0.014 inch filterwire was successfully inserted through this device with no resistance experienced.The guidewire used by the customer was not returned for analysis.A visual and tactile examination identified no issues with the catheter or delivery system.The device was returned with the stent fully mounted in the correct location on the device.

Event Description

It was reported that entrapment on guidewire occurred.Vascular access was gained via the femoral artery.The 70% stenosed target lesion was located in the non tortuous and severely calcified venous sinus.A 8.0-36 carotid wallstent was selected for use.During the procedure, the device was unable to cross the lesion and became stuck on the 0.14 guidewire.Another of the same device was used to complete the procedure.There were no patient complications, and the patient status was stable.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15680562
• MDR Text Key: 302517953
• Report Number: 2124215-2022-43470
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0029228117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2022
• 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
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 58 KG