MAUDE Adverse Event Report: BIOSENSE WEBSTER BIOSENSE WEBSTER; PENTARAY CATHETER

Catalog Number D128210

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 12/12/2016

Event Type  Injury  

Event Description

Patient s/p and fibrillation ablation yesterday.During procedure, pentaray catheter was caught and broke off in mechanical mitral valve, leaving leaflet closed.One functional leaflet.Patient had emergent heart cath in the case of patient requiring emergent surgery for valve.Coronaries patent.Patient stable, denies pain, shortness of breath.

• Brand Name: BIOSENSE WEBSTER
• Type of Device: PENTARAY CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER; phoenix AZ 85016
• MDR Report Key: 6185344
• MDR Text Key: 62842341
• Report Number: MW5066743
• Device Sequence Number: 1
• Product Code: MTD
• 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: 12/13/2016

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 Expiration Date: 08/31/2016
• Device Catalogue Number: D128210
• Device Lot Number: 17564900L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 MO
• Patient Weight: 45