MAUDE Adverse Event Report: WILCON-COOK MEDICAL INC. SAVARY-GILLARD GUIDEWIRE

Model Number SGW-200-SD

Device Problem Bent (1059)

Patient Problems Perforation (2001); Dysphasia (2195)

Event Date 05/22/2017

Event Type  Injury  

Event Description

Patient was in our endoscopy unit for an elective upper gi endoscopy due to dysphasia.The patient's esophagus was found to have a web and be very small so dilation was attempted.As the dilator was being passed over the savary guidewire there was resistance felt by the provider.The instruments were pulled out and a false passage was noted upon inspection.At this time it was noted the guidewire was bent at a severe angle at the top of the flexible tip and looked to be very fragile.The patient was positive for perforation which is being treated conservatively to this point with antibiotics and npo status.

• Brand Name: SAVARY-GILLARD GUIDEWIRE
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): WILCON-COOK MEDICAL INC.
• MDR Report Key: 6629604
• MDR Text Key: 77308917
• Report Number: MW5070265
• Device Sequence Number: 1
• Product Code: OCY
• 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: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SGW-200-SD
• Device Catalogue Number: G22139
• 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 Outcome(s): Hospitalization
• Patient Age: 69 YR