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

Model Number	26665
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an entrapment on the guidewire occurred.The 40-50% stenosed target lesion was located in the mildly tortuous and moderately calcified left internal carotid artery.An 8x29, 5f, 135cm carotid monorail was advanced to assist in deploying a carotid wallstent.Deployment was successful, but the wallstent catheter was stuck on the distal protection device wire of a non-bsc device and could not removed, thus, was entrapped.The physician attempted to free the catheter by pinning it and advancing the wire, but was unsuccessful.The entire system was taken out together with both devices as one unit.The catheter remained stuck after it was retrieved.The procedure was completed successfully.
Additional Manufacturer Narrative
The stent was returned to the manufacturer for analysis deployed from the delivery system.A visual and tactile examination identified no issues with the catheter or delivery system.The non-bsc guidewire that was used together with the carotid monorail was kinked.It was confirmed this stent met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.
Event or Problem Description
It was reported that an entrapment on the guidewire occurred.The 40-50% stenosed target lesion was located in the mildly tortuous and moderately calcified left internal carotid artery.An 8x29, 5f, 135cm carotid monorail was advanced to assist in deploying a carotid wallstent.Deployment was successful, but the wallstent catheter was stuck on the distal protection device wire of a non-bsc device and could not removed, thus, was entrapped.The physician attempted to free the catheter by pinning it and advancing the wire, but was unsuccessful.The entire system was taken out together with both devices as one unit.The catheter remained stuck after it was retrieved.The procedure was completed successfully.It was further confirmed that there was resistance encountered during the removal of the stent delivery system over the wire.

• Brand Name: CAROTID WALLSTENT
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18360737
• Report Number: 2124215-2023-72053
• Device Sequence Number: 20836750
• Product Code: NIM
• UDI-Device Identifier: 08714729781202
• UDI-Public: 08714729781202
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P050019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26665
• Device Catalogue Number: 26665
• Device Lot Number: 0032188276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male