MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGTOME RX 39; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00573090

Device Problems Break (1069); Failure to Fold (1255)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a jagtome rx 39 was to be used in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during preparation, a break in the cutting wire was observed and the device would not bow.The procedure was completed with another jagtome rx 39.There were no patient complications reported as a result of this event.

• Brand Name: JAGTOME RX 39
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10076516
• MDR Text Key: 193973171
• Report Number: 3005099803-2020-02012
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729776550
• UDI-Public: 08714729776550
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2022
• Device Model Number: M00573090
• Device Catalogue Number: 7309
• Device Lot Number: 0024472524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2019
• 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