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 No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: estimated.Device evaluated by mfr: the unit was returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The unit was returned with a unknown guidewire.The proximal filter was returned un-sheathed.The distal filter was returned un-sheathed and inverted with the strut tube broken.The articulating sheath (ads) was relaxed.The inner member was returned without visible damages under the rear handle shells.Flushing was achieved in all flush ports.Microscopic inspection of the device revealed no damages to the distal filter member.The location of the strut tube break was confirmed.A test guide wire was fully inserted for functional testing.The proximal filter sheathed and un-sheathed using the proximal filter slider (#1).The ads responded as expected when turning the articulating knob (#2).The distal filter slider (#3) was pulled and no friction was felt; however, sheathing of the distal filter was stopped due to the strut tube damage.

Event Description

Reportable on returned device analysis completed 18 sept 2020.A sentinel cerebral protection system was returned with no reported allegation.Upon analysis, a distal filter break was discovered.

• 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: 10586760
• MDR Text Key: 208549124
• Report Number: 2134265-2020-13210
• Device Sequence Number: 1
• Product Code: PUM
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• 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: 08/26/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1