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 08/22/2019

Event Type  malfunction  

Event Description

It was reported that the distal filter was unable to be retrieved both filters were able to be deployed.At the end of the case, the sentinel device showed a lot of resistance in retrieving the distal filter.When trying to retrieve the distal filter, the #3 distal filter slider completely pulled out of the back of the sentinel handle.The device was successfully removed with the distal filter still deployed and no harm to the patient occurred.

Event Description

It was reported that the distal filter was unable to be retrieved.Both filters were able to be deployed.At the end of the case, the sentinel device showed a lot of resistance in retrieving the distal filter.When trying to retrieve the distal filter, the #3 distal filter slider completely pulled out of the back of the sentinel handle.The device was successfully removed with the distal filter still deployed and no harm to the patient occurred.It was further reported that there was resistance in deploying the distal filter.The distal filter was only deployed once.

Event Description

It was reported that the distal filter was unable to be retrieved.Both filters were able to be deployed.At the end of the case, the sentinel device showed a lot of resistance in retrieving the distal filter.When trying to retrieve the distal filter, the #3 distal filter slider completely pulled out of the back of the sentinel handle.The device was successfully removed with the distal filter still deployed and no harm to the patient occurred.It was further reported that there was resistance in deploying the distal filter.The distal filter was only deployed once.

Manufacturer Narrative

Analysis of the returned unit showed the guidewire used was returned still inside the device (coming out from both sides), the distal filter slider (#3) and inner member were found detached, inner member buckling was also visible.Distal filter was already deployed when received.Flush test was performed and flushing could be achieved only through front handle flush port.Removal of guidewire was attempted, as soon as resistance was felt removal was stopped; guidewire remained stuck on the device.Both the proximal filter and the articulating sheath performed as expected nonetheless, the distal filter slider (#3) could not be tested due to distal filter slider (#3) damage.Additional inspection was performed in order to look further into the issue.Handle shells were removed, and inner member buckling/detachment location was visible.Sheath and core wire were cut in order to make gain access to the inner member; guidewire stuck could not be pulled out however, the distal filter was able to be deployed/retracted by manually moving the inner member; supported by the piece of the guidewire still in the tip.Articulation sheath was cut transversally and no damages were found.Reported complaint of distal filter difficult to deploy could not be confirmed as the distal filter was returned deployed.Distal filter failure to capture/retrieve was confirmed, and reported issue of handle break was confirmed due to distal filter slider (#3) detachment.There is no objective evidence indicating that the device was intentionally used against the dfu indications.

• 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: 9081858
• MDR Text Key: 158994221
• Report Number: 2134265-2019-11106
• Device Sequence Number: 1
• Product Code: PUM
• 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,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1