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

Model Number 26605

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 04/20/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: carotid wallstent monorail was returned for analysis.This carotid device is recommended for use with a guidewire.During the product analysis a boston scientific 0.014 filter wire could not be advanced through the device due to a complete shaft separation.The guidewire used by the customer was not returned for analysis.A visual and tactile examination found the shaft of the device to be completely detached at the monorail port.This type of damage is consistent with excessive force being applied to the device.The device was returned with the stent fully mounted in the correct location on the device.

Event Description

Reportable based on device analysis completed on (b)(6) 2022.It was reported that difficulties in loading the wire were encountered.The target lesion was located in left internal neck.A 8.0-29 carotid wallstent stent was selected for use.However, during insertion of a 0.014 guidewire, it could not get through the monorail channel.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable following the procedure.However, returned device analysis revealed that shaft was completely separated/detached at the monorail port.

• 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: 15310569
• MDR Text Key: 302498167
• Report Number: 2124215-2022-29682
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• 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: 0028692414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2022
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 63 KG