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

Model Number CMS15-10C-US

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2020

Event Type  malfunction  

Event Description

It was reported that an inability to resheath the distal filter occurred.Vascular access was obtained via a right radial approach.A.035 guide wire and 6f impulse im catheter were advanced through the right radial approach into the right brachiocephalic artery.The.035 guide wire was removed and exchanged for a 300cm choice pt extra support guide wire.The choice pt extra support wire was advanced with the 6f impulse im catheter to access the left common carotid (lcc) artery.The choice pt guide wire was advanced into the lcc and the 6f impulse im catheter was removed.The sentinel cerebral protection system (cps) was loaded on the choice pt extra support guide wire and advanced to the right brachiocephalic and into the lcc.The proximal filter was deployed.The distal catheter prolapsed back out of the lcc and was then maneuvered into the lcc with standard deployment techniques.The lcc filter was deployed meeting some initial resistance.Following the successful procedure, distal filter slider was pulled back to resheath the distal filter.The distal filter slider broke off from the handle.The distal filter was not able to be resheathed.The physician decided to open up the rear handle and was able to pull on the inner shaft to resheath the distal filter.The sentinel cps was removed successfully and there were no issues with the patient.

• 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): BOSTON SCIENTIFIC CORPORATION; 160 knowles drive; los gatos CA 95032
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10549041
• MDR Text Key: 207539171
• Report Number: 2134265-2020-12197
• 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: 09/17/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2022
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0025667800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1