MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) JAGTOME¿ RX 39; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00573080

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

Reported event of corewire broken.Visual analysis of the guidewire revealed the hydrophilic tip was detached exposing the metal corewire.Moreover, the distal corewire tip was broken and bent.The complaint is consistent with the reported event of distal tip detached/separated.It is most probable that an excess force applied during the procedure could have generated the failure encountered.Based on all gathered information, the most probable root cause is "operational context¿.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a jagtome¿ rx 39 was used in the common bile duct, papilla, pancreatic duct, and duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2016.According to the complainant, during the procedure, it was noticed that the hydrophilic tip detached.Reportedly, the staff could not find the broken piece of the guidewire.They used a second jagtome¿ rx 39 to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed reportable based on the investigation results: the distal tip of the guidewire was broken (core wire broken).

• Brand Name: JAGTOME¿ RX 39
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6338225
• MDR Text Key: 67655407
• Report Number: 3005099803-2017-00328
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729776642
• UDI-Public: (01)08714729776642(17)20190823(10)19630946
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2019
• Device Model Number: M00573080
• Device Catalogue Number: 7308
• Device Lot Number: 19630946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1