MAUDE Adverse Event Report: BOSTON SCIENTIFIC HYDRATOME RX44 0.035IN X 260CM; SPHINCTEROTOME

Model Number 08714729755197

Device Problem Failure to Align (2522)

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

Event Date 07/05/2016

Event Type  malfunction  

Event Description

Boston scientific hydratome rx44 sphincterotome catheter tip alignment significantly angled to the right when coming out of duodenoscope, unable to be used, another device used without problems.Diagnosis: ercp.

• Brand Name: HYDRATOME RX44 0.035IN X 260CM
• Type of Device: SPHINCTEROTOME
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA 01752
• MDR Report Key: 5781760
• MDR Text Key: 49255569
• Report Number: MW5063315
• Device Sequence Number: 1
• Product Code: KNS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2019
• Device Model Number: 08714729755197
• Device Catalogue Number: M00583040
• Device Lot Number: 19258612
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16 YR