MAUDE Adverse Event Report: BOSTON SCIENTIFIC TWISTER PLUS; RESOLUTION CLIP

Catalog Number M00522610

Device Problems Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/18/2016

Event Type  Injury  

Event Description

Intra procedure material equipment, rothnet and hemoclip, malfunction.Hemoclip released grasp upon deploying.Rothnet not closing to retrieve object to be removed.

• Brand Name: TWISTER PLUS
• Type of Device: RESOLUTION CLIP
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA 01752
• MDR Report Key: 6121405
• MDR Text Key: 60781721
• Report Number: MW5066239
• Device Sequence Number: 1
• Product Code: PKL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2019
• Device Catalogue Number: M00522610
• Device Lot Number: ML001311C5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR
• Patient Weight: 90