MAUDE Adverse Event Report: BOSTON SCIENTIFIC HYDRATOME RX 44 SPHINCTEROTOME ; UNIT, ELECTROSURGICAL, ENDOSCOPIC

Model Number 08714729755197

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2017

Event Type  malfunction  

Event Description

Boston scientific hydratome rx44 sphincterotome tip with cutting wire would not fully bend when the physician was attempting to perform the sphincterotomy.

• Brand Name: HYDRATOME RX 44 SPHINCTEROTOME
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): BOSTON SCIENTIFIC ; marlborough MA 01752
• MDR Report Key: 7002883
• MDR Text Key: 91247145
• Report Number: MW5073141
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2020
• Device Model Number: 08714729755197
• Device Catalogue Number: 08714729755197
• Device Lot Number: 21058725
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Age: 71 YR