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

Model Number CMS15-10C-US

Device Problem Entrapment of Device (1212)

Patient Problems Failure to Anastomose (1028); Endocarditis (1834); Fever (1858); Perforation of Vessels (2135)

Event Date 11/11/2022

Event Type  Injury  

Event Description

Patient is an adult male with medical history of hypertension, status post aortic valve replacement, diabetes mellitus type 2, obstructive sleep apnea , hyperlipidemia, strep mitis bacteremia on ceftriaxone, chronic vertigo who presented to emergency department with fever.Concern for ongoing endocarditis with possible septic emboli to the brain and distal splenic artery with evidence of hypodensity in the right genu of the corpus callosum and splenic infarction.Patient underwent an unsuccessful mass extraction of the aortic valve vegetation.During the procedure upon trying to retrieve the right sentinel device, it got stuck in the right radial artery and multiple techniques were tried to retrieve it, all were unsuccessful.Vascular surgery was called emergently to the room where a cut down was performed in order to retrieve the retained piece of the sentinel.It was noted that the radial artery was completely destroyed, unable to be salvaged as it was completely wrapped around the device in a spiral fashion.The radial artery was transected and distal stump ligated.Vascular access sites stable.Right had warm and well perfused, appears to have appropriately compensated blood supply from the right ulnar artery.

• 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: 15864648
• MDR Text Key: 304295466
• Report Number: 15864648
• 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: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0028876210
• 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: 11/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 21535 DA
• Patient Sex: Male