MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENTINEL; TEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRACARDIAC PROCEDURES

Model Number CMS15-10C-US

Device Problems Break (1069); Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2021

Event Type  malfunction  

Event Description

During placement of sentinel device, the number 3 piece of the device was pulled and broke off from device.Multiple attempts were made to place wire to straighten device, in order to pull device out of body.Wire was eventually introduced through lumen after distal end of device was cut.Wire straightened catheter and then was removed from the body intact.This sentinel deployment was difficult.The first filter was deployed very nicely, but we were unable to deploy the second filter, likely associated with significant radial tortuosity and a radial loop.We attempted to pass a platinum plus wire through the system, exchanging it for a choice pt, but the wire unfortunately would not pass and there remained significant tension buildup in the wire.At this point, our only option was to pull the system back in a very careful manner under fluoroscopic visualization, which was successful.We were then able to cut the device.In the midportion of the device, we advanced a platinum plus wire, carefully straightening out the sentinel device as it was in the midportion of the radial artery.This was successful.We were able to remove the device and sheath from the body as a near-single unit.

• Brand Name: SENTINEL
• Type of Device: TEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRACARDIAC PROCEDURES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11692636
• MDR Text Key: 246265088
• Report Number: 11692636
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/15/2021

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 Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 26564781
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30660 DA
• Patient Weight: 86