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Adverse Event Report

BARD INTERVENTIONAL PRODUCTS ENDOSCOPIC OVERTUBE   back to search results
Catalog Number 000-230
Event Date 09/26/1995
Patient Outcome  Hospitalization; Required Intervention
Event Description

Pt in having esophageal varices. Egd-demonstrated large varices again seen x 4 in distal esophaus. There was no evidence of acstive bleeding. The stomach was enterd, again was free of ulcerations. The stomach did not show multiple petachial lesions suggestive of angiodyplastic lesions of gastritis. The endoscope was then pulled back into the esophagus. Teh overtube was advanced over the endoscope. The endoscope was then removed and the banding apparatus replaced over the end of the endoscope. The endoscope was then re-introduced through the overtube and into the esophagus and down to the distal esophagus. There, one varice was identified and properly banded without difficulty. At this point the endoscope with the banding device was withdrawn. Attempts to withdraw it through the overtube were proved impossible and therefore, the entire overtube and endoscope needed to be removed. Upon reintroducing the endoscope through the oropharynx, rptr discovered a large defect in the esophagus approx 2. 5 cm beyond the vocal cords. The vocal cords were undisturbed and normal. The defect was in the form of a pouch and because of concern of a perforation, rptr immediately consulted the chief of surgery and the chief of surgery and the chief of ent, who both confirmed the defect. The decisions of the surgeons was to terminate the study and proceed with further evaluation of this possible esophageal tear. A gastrografin esophageal swallow was performed when the pt woke up and the tear was confirmed. The pt was returned to surgery for repair of the esophagus. Drainage tube inserted and pt intubated and on ventilator post op due to difficult intubation due to osteoarthritis, due to anticipated laryngeal edema pt left intubated.

 
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Brand NameENDOSCOPIC OVERTUBE
Type of DeviceOVERTUBE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BARD INTERVENTIONAL PRODUCTS
5 federal st
p.o. box 5069
billerica MA 01822
Manufacturer (Section D)
BARD INTERVENTIONAL PRODUCTS
5 federal st
p.o. box 5069
billerica MA 01822
Device Event Key32053
MDR Report Key30997
Event Key29068
Report Number30997
Device Sequence Number1
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 10/25/1995
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/29/1996
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number000-230
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/26/1995
Device Age5 mo
Event Location Hospital
Date Report TO Manufacturer10/25/1995
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on December 31, 2008

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