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

Model Number CMS15-10C-US

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

Event Type  malfunction  

Event Description

It was reported that a distal filter detachment occurred.The procedure was successfully completed with the use of a sentinel cerebral protection system.No patient complications occurred.After the procedure, the sentinel cerebral protection system was inspected outside the patient the distal filter slider was pulled out to flush the distal filter and the entire distal filter section became detached from the main sentinel cerebral protection system catheter.

Event Description

It was reported that a distal filter detachment occurred.The procedure was successfully completed with the use of a sentinel cerebral protection system.No patient complications occurred.After the procedure, the sentinel cerebral protection system was inspected outside the patient the distal filter slider was pulled out to flush the distal filter and the entire distal filter section became detached from the main sentinel cerebral protection system catheter.

Manufacturer Narrative

H3: device eval by manufacturer: the sentinel cerebral protection system was returned in a generic plastic bag.Overall visual inspection did not identify failures or evidence that could be lost due to the decontamination process.Visual inspection revealed that the sentinel cerebral protection system was returned with the proximal filter sheathed, the articulating distal sheath(ads) relaxed, the distal filter slider (#3) in deployment position, and the distal filter assembly detached from the inner member, which was not returned.The distal section of the inner member was inspected under ultraviolet(uv) light and confirmed presence of adhesive where the distal filter assembly should be.Under microscopic examination, the distal filter assembly detachment was confirmed.The distal section of the inner member was microscopically inspected and no issues were detected.A picture was returned with the sentinel cerebral protection system showing the distal filter of the sentinel cerebral protection system detached from the inner member; additionally, the strut tube is broken and the distal filter is inverted.However, this will not be considered as failures since as per event information, the team intentionally inverted the distal filter when flushing, post-procedure to observe the debris.

• 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
• MDR Report Key: 10671593
• MDR Text Key: 211314893
• Report Number: 2134265-2020-13849
• Device Sequence Number: 1
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: 00863229000004
• Combination Product (y/n): N
• PMA/PMN Number: DEN160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

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: 01/21/2022
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0025086338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 12/21/2020
• Supplement Dates FDA Received: 01/05/2021
• Patient Sequence Number: 1