MAUDE Adverse Event Report: BIOLOGICS CONSULTING GROUP, INC. ESOPHAGEAL TTS; PROSTHESIS, ESOPHAGEAL

Catalog Number EST2010F

Device Problem Failure to Fire (2610)

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

Event Date 08/07/2018

Event Type  malfunction  

Event Description

The esophageal tts stent was placed down the biopsy channel in the egd therapeutic scope by the gi physician.When the gi technician went to deploy the stent, the stent would not deploy from the catheter.

Event Description

The esophageal tts stent was placed down the biopsy channel in the egd therapeutic scope by the gi physician.When the gi technician went to deploy the stent, the stent would not deploy from the catheter.

• Brand Name: ESOPHAGEAL TTS
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BIOLOGICS CONSULTING GROUP, INC.; 1555 king street, suite 300; 1555 king street, suite 300; alexandria VA 22314
• MDR Report Key: 7859695
• MDR Text Key: 119669377
• Report Number: 7859695
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

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 Catalogue Number: EST2010F
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2018
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Weight: 72