MAUDE Adverse Event Report: CLARET MEDICAL, INC. SENTINEL CEREBRAL PROTECTION SYSTEM (US); EMBOLIC PROTECTION DEVICE

Model Number CMS15-10C-US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/12/2019

Event Type  Injury  

Event Description

It was reported that compartment syndrome occurred.A sentinel cerebral embolic protection device was used in a tavr procedure where a non-bsc valve was implanted and a 30mm watchman device was deployed.There were no procedural complications reported.No injury to the radial artery was evident, nor significant forearm hematoma where the sentinel device had been inserted.There was a small amount of blood in the musculature of the forearm.Immediately on arrival to the icu, compartmental syndrome was discovered.A fasciotomy was performed.There was a holding of anticoagulation and transfusion and adjustment of coumadin levels prior to discharge nine (9) days later.The patient was doing well in rehab; however, developed e coli urinary tract infection.The patient was not feeling well, and noted to have right leg swelling.The patient went into pea/asystole arrest.Cpr was started.The patient died with principle causes of death listed as lactic acidosis, acute chronic renal failure, septic shock, e coli urinary tract infection.The death was not related to the sentinel device.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM (US)
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): CLARET MEDICAL, INC.; 1745 copperhill parkway; santa rosa CA 95403
• Manufacturer (Section G): CLARET MEDICAL, INC.; 1745 copperhill parkway; santa rosa CA 95403
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8870365
• MDR Text Key: 153562861
• Report Number: 2134265-2019-08892
• Device Sequence Number: 1
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: 00863229000004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 19D16H23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2019
• 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 Outcome(s): Other
• Patient Age: 87 YR