MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP JAGTOME 44 RX; NONE

Lot Number 20328678

Device Problems Break (1069); Detachment Of Device Component (1104); Wire(s), breakage of (2347)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2017

Event Type  malfunction  

Event Description

During an ercp using the jagtome 44 rx device the sphincterotome wire used during the sphincterotomy broke off from one end of the device.The device was removed via the ercp scope and no harm was done to the pt.It has been reported by staff that this has occurred during previous procedures.

• Brand Name: JAGTOME 44 RX
• Type of Device: NONE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP ; 500 commander shea blvd; quincy MA 02171
• MDR Report Key: 6563329
• MDR Text Key: 75187995
• Report Number: 6563329
• Device Sequence Number: 1
• Product Code: KNS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 20328678
• Other Device ID Number: 7304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2017
• Distributor Facility Aware Date: 05/01/2017
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other