MAUDE Adverse Event Report: CONMED CORPORATION CLEANGUIDE DISPOSABLE MARKED SPRING TIP GUIDEWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number DIS150

Device Problem Material Twisted/Bent (2981)

Patient Problem Perforation (2001)

Event Date 01/25/2022

Event Type  Injury  

Event Description

Patient having esophageal dilation for diffuse esophageal spasms.During dilations the guidewire for dilation became imbedded in esophagus, a tear occurred in the distal esophagus which was repaired with an ovesco clip.The guidewires may appear easier to kink with manipulation.Also, a perforation of the upper esophageal sphincter occurred which required a left cervical neck exploration/drainage and peg tube placement.Fda safety report id# (b)(4).

Event Description

Patient having esophageal dilation for diffuse esophageal spasms.During dilations the guidewire for dilation became imbedded in esophagus, a tear occurred in the distal esophagus which was repaired with an ovesco clip.The guidewires may appear easier to kink with manipulation.Also, a perforation of the upper esophageal sphincter occurred which required a left cervical neck exploration/drainage and peg tube placement.Fda safety report id# (b)(4).

• Brand Name: CLEANGUIDE DISPOSABLE MARKED SPRING TIP GUIDEWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): CONMED CORPORATION; utica NY 13502 5994
• MDR Report Key: 13453954
• MDR Text Key: 285172016
• Report Number: MW5107202
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• 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: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIS150
• Device Catalogue Number: DIS150
• Device Lot Number: 202112075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OVESCO CLIP; PEG TUBE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White