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

Lot Number 28715458

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/07/2022

Event Type  Injury  

Event Description

Sentinel device for embolic protection used with tavr procedure.At end of case difficulty withdrawing device at level of the radial sheath.Multiple attempts performed.Finally, sheath and sentinel removed en bloc.A piece of wire was discovered inside of the radial sheath.Fda safety report id # (b)(4).

• Brand Name: SENTINEL
• Type of Device: TEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRACARDIAC PROCEDURES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 15016193
• MDR Text Key: 295996290
• Report Number: MW5110855
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 28715458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White