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

Model Number CMS15-10C

Device Problems Difficult or Delayed Positioning (1157); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: visual inspection revealed the distal filter hypotube is bent, front handle shells are split open.The proximal filter attempted to be sheathed with handles separated; however the device failed functional testing as the proximal filter failed to deploy and resheath.Adhesive around proximal filter is loose causing brunching of filter material.The dhr review was performed on lot number 18h06h03.And shows that all acceptance records demonstrate that the device was manufactured in accordance with the device master record.The conclusion code is unintended use error caused or contributed to event.The ifu states "repositioning, if required, should only occur during initial placement and the proximal filter should be re-sheathed prior to re-positioning".The event description suggests the proximal filter was attempted to be sheathed with handles separated.

Event Description

Reportable on analysis completed 03 january 2019.It was reported that failure to deploy the filter occurred.Vascular access was obtained via a radial artery approach.A sentinel embolic protection device was advanced.The sentinel device was prepared step by step as usual and no abnormality was noticed.When the device reached aorta and ready to deploy the proximal filter in bcc, the filter could not fully open, so dr lam tried to retrieve the filter back to catheter but failed.Consider patient safety dr lam decided to remove the whole system from patients body.They examine the device upon retrieved and found the handle was broken.Finally, doctor used a new piece of sentinel (same lot) to continue the case without any problem.The patient's status is stable.However, returned device analysis revealed loose filter adhesive.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): CLARET MEDICAL, INC.; 1745 copperhill parkway; santa rosa CA 95403
• Manufacturer (Section G): CLARET MEDICAL, INC.; 1745 copperhill parkway; santa rosa CA 95403
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8290937
• MDR Text Key: 134571326
• Report Number: 2134265-2019-00576
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2019

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: 07/31/2020
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 18H06H03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1