MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) HYDRATOME¿ RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00583040

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a hydratome¿ rx 44 was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) with anesthesia procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the nurse had bowed and straightened the sphincterotome multiple times with no issues while cannulating the ampulla and had it bowed while the physician was performing the sphincterotomy.Halfway through the sphincterotomy, the nurse felt something "give" and the physician was no longer able to cut.When they pulled the scope back and looked at the end of the sphinterotome, they noticed that the wire had snapped in half.There was no part of the device detached inside the patient.Reportedly, they used the same generator and active cord during the procedure, but used a second hydratome¿ rx 44 to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the end of the procedure was reported to be stable.

• Brand Name: HYDRATOME¿ RX 44
• 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: 7772209
• MDR Text Key: 116732498
• Report Number: 3005099803-2018-02520
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729755197
• UDI-Public: 08714729755197
• 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: Physician
• Type of Report: Initial
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2021
• Device Model Number: M00583040
• Device Catalogue Number: 8304
• Device Lot Number: 22084931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2018
• 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
• Patient Age: 83 YR