MAUDE Adverse Event Report: BOSTON SCIENTIFIC AUTOTOME RX39; SPHINCTEROTOME, 3.9F

Model Number M00545200

Device Problem Material Distortion (2977)

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

Event Date 04/02/2015

Event Type  malfunction  

Event Description

Once passed through the endoscope, the boston scientific autotome rx39 tip presented at a distorted angle (not the usual, normal presentation) making it difficult to perform the intended procedure.Another "like" device was utilized without issue.Reason for use: ercp, sphincterotomy.

• Brand Name: AUTOTOME RX39
• Type of Device: SPHINCTEROTOME, 3.9F
• Manufacturer (Section D): BOSTON SCIENTIFIC; natick MA 01760
• MDR Report Key: 4684167
• MDR Text Key: 18093527
• Report Number: MW5042051
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2017
• Device Model Number: M00545200
• Device Catalogue Number: M00545200
• Device Lot Number: 17397446
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR