MAUDE Adverse Event Report: BOSTON SCIENTIFIC OBTRYX II SYSTEM; OBTRYX II SYSTEM

Model Number 850-511

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/01/2016

Event Type  malfunction  

Event Description

During deployment of boston scientific obtryx ii system halo.The plastic delivery sheath broke leaving an approx 2.5" piece in pt's right groin.After search of right groin wound with no results, no further exploration was made.Wound irrigated with antibiotics and closed.Called boston scientific complaint phone number: (b)(4) to register malfunction of product on 01/20/2017 at 1455 or 2:55pm.

• Brand Name: BOSTON SCIENTIFIC OBTRYX II SYSTEM
• Type of Device: OBTRYX II SYSTEM
• MDR Report Key: 6271166
• MDR Text Key: 65929778
• Report Number: 6271166
• Device Sequence Number: 1
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/20/2017

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: 10/01/2017
• Device Model Number: 850-511
• Device Catalogue Number: 850-511
• Device Lot Number: ML00002683
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2017
• Distributor Facility Aware Date: 12/01/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR