MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENTINEL CEREBRAL PROTECTION SYSTEM; EMBOLIC PROTECTION DEVICE

Model Number CMS15-10C

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2021

Event Type  malfunction  

Event Description

It was reported that a failure to resheath the distal filter occurred.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve implantation (tavi) procedure.The proximal filter of the sentinel cps was successfully deployed in the brachiocephalic artery.After placement of the proximal filter, the articulating sheath was curved but there was difficulty accessing the left common carotid (lcc) artery.Several attempts to enter the lcc were made.The articulating sheath was straightened and recurved to improve the ability to access the lcc.At this point the physician felt tension in the system and attempted to change out the guidewire but was unable to do so.The sentinel cps was removed from the patient, reflushed and readvanced into the patient.The proximal filter of the sentinel cps was deployed easily.The physician experienced no resistance when curving the articulating sheath and was able to cannulate the lcc without difficulty.When deploying the distal filter, resistance was encountered.It was observed that the corewire did not extend as far as expected and the distal filter had deployed at the tip of the articulating sheath.The tavi procedure proceeded without incident.When the sentinel cps was being retrieved, the distal filter slider on the handle of the sentinel cps broke and the physician was unable to recapture the distal filter.The proximal filter was retrieved and the sentinel cps was removed from the patient with the distal filter in an open state.There were no reported patient complications.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 3636 n. laughlin blvd, suite 1; santa rosa CA 95403
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12685539
• MDR Text Key: 278097921
• Report Number: 2134265-2021-12761
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K192460
• 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: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2022
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 0026397905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2020
• 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
• Patient Age: 78 YR