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 to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2019

Event Type  malfunction  

Event Description

It was reported that the distal filter capture failure occurred.Procedure summary: a sentinel embolic protection device was placed and the filters deployed.When the physician attempted to recapture the distal filter, the handle broke and the filter could not be retrieved.The physician was able to retrieve the filter by using a clamp to pull on the hypotube.No patient complications were reported.The patient is fine.

Event Description

It was reported that the distal filter capture failure occurred.Procedure summary: a sentinel embolic protection device was placed and the filters deployed.When the physician attempted to recapture the distal filter, the handle broke and the filter could not be retrieved.The physician was able to retrieve the filter by using a clamp to pull on the hypotube.No patient complications were reported.The patient is fine.

Manufacturer Narrative

H3 device evaluated by mfr: analysis of the returned product revealed there was blood residue in multiple parts of the device, the articulating distal sheath (ads) was slightly flexed, proximal filter was found sheathed, and the distal filter returned un-sheathed and there is a small kink in its tri-layer.It was also noted that the distal filter slider (#3) came back detached from the catheter and inside an introducer, and part of the inner member was exposed (outside the rear handle) and damaged.Flushing was only achieved through the front handle flush port and, due to device conditions, no functional testing was performed.The reported complaints of handle break and distal filter failure to capture/retrieve were confirmed due to device condition.In order to look further into the issue, the distal filter slider (#3) was removed from the introducer, without any force, and sent for x-ray analysis.It was noted that there were no inner member pieces found inside the detached distal filter slider (#3).Pin gages were inserted into the distal filter slider hypotube, and a 0.028" pin gage was inserted successfully and advanced about 5 mm before stopping; indicating there is an obstruction inside the hypotube (most likely part of the filler tube).Product analysis found a kink in the distal filter tri-layer and complete distal filter slider (#3) detachment; part of the inner member was exposed (outside the rear handle) and damaged.Further analysis found there were no inner member remains inside the distal filter slider.Insertion of pin gages confirmed a 0.028" pin gage could not be inserted, which indicates obstruction.

• 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: 9576100
• MDR Text Key: 178015092
• Report Number: 2134265-2019-16692
• 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
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• 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: 01/14/2020
• Date Manufacturer Received: 03/12/2020
• Patient Sequence Number: 1