MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. BOSTON SCIENTIFIC 7F SPLIT SHEATH KIT WITH VALVE AND SIDEPORT; INTRODUCER, CATHETER

Catalog Number M0D4 8087001

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

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

Event Date 07/18/2022

Event Type  malfunction  

Event Description

During pacemaker insertion, sheath broke during 'peel­ away' dislodging atrial lead.

• Brand Name: BOSTON SCIENTIFIC 7F SPLIT SHEATH KIT WITH VALVE AND SIDEPORT
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.
• MDR Report Key: 15094920
• MDR Text Key: 296604167
• Report Number: MW5111091
• Device Sequence Number: 1
• Product Code: DYB
• 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
• Type of Report: Initial
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M0D4 8087001
• Device Lot Number: Q1868740
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 157 KG