MAUDE Adverse Event Report: BOSTON SCIENTIFIC ULTRA ICE 9MH2 CATHETER; INTRA CARDIAC ECHO CATHETER

Catalog Number 9900

Device Problems Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/11/2015

Event Type  malfunction  

Event Description

During procedure to treat atrial fibrillation, tip of catheter broke off and lodged in pelvis area.

• Brand Name: ULTRA ICE 9MH2 CATHETER
• Type of Device: INTRA CARDIAC ECHO CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC; freemont CA 94538
• MDR Report Key: 5011202
• MDR Text Key: 23390007
• Report Number: MW5055468
• Device Sequence Number: 1
• Product Code: ITX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2017
• Device Catalogue Number: 9900
• Device Lot Number: 17640533
• Other Device ID Number: REF # 9900
• 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): Other
• Patient Age: 30 YR