MAUDE Adverse Event Report: BOSTON SCIENTIFIC 20MM CUT WIRE; HYDRATOME RX44

Catalog Number M00583040

Device Problem Malposition of Device (2616)

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

Event Date 10/06/2016

Event Type  malfunction  

Event Description

Tip does not have proper orientation after metal stylet removed.

• Brand Name: 20MM CUT WIRE
• Type of Device: HYDRATOME RX44
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA
• MDR Report Key: 6078447
• MDR Text Key: 59287692
• Report Number: MW5065798
• 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: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M00583040
• Device Lot Number: 19561856
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7 MO
• Patient Weight: 75