MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENTINEL; TEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRACARDIAC PROCEDURES

Model Number CMS15-10C-US

Device Problems Component Missing (2306); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

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

Event Date 08/17/2021

Event Type  malfunction  

Event Description

Sentinel cerebral protection system was packaged without stylet in wire port; upon inspection, device seemed to be appropriate to use.Due to very tortuous anatomy, sentinel device was unable to smoothly advance through innominate artery and up left common carotid, device was removed, and a different stiffer guidewire was advanced to attempt to deliver sentinel protection.Device was still unable to be delivered and was removed.Upon inspection of device, the wire port in the distal filter that sits in the left common carotid was kinked and not smooth as it normally is.A second new sentinel device was prepped and delivered successfully following the removal following the first device.Successful procedure performed w/o harm to patient.

• Brand Name: SENTINEL
• Type of Device: TEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRACARDIAC PROCEDURES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12364692
• MDR Text Key: 268068270
• Report Number: 12364692
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 27554522
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29930 DA
• Patient Weight: 102