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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR DH EF PERC PLACEMENT PRODUCTS

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AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR DH EF PERC PLACEMENT PRODUCTS Back to Search Results
Model Number 98433
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/12/2021
Event Type  malfunction  
Event Description
It was reported via fda medwatch / fda user facility report # (b)(4). The following information: during ct (computed tomography) guided ir (interventional radiology) percutaneous gastrostomy tube placement, a segmented telescoping dilator and peel-away sheath was then advanced over the wire at the central access point and dilation was performed. Then removed; this required greater than expected force which was thought to be due to kinking of the wire for dilator. We then tried to advance an 18 french gastrostomy tube into the peel­ away sheath without success. It was subsequently noted that a portion of the telescoping dilator was still situated within the peel-away sheath, this was grasped and removed with hemostats. The tube was then successfully placed through the peel-away sheath which was then peeled and withdrawn. At this point, the technologist noted that an additional portion of the telescoping dilator was not on the procedure tray we rescanned the patient which demonstrated the gastrostomy tube with inflated balloon in appropriate position and a subtle radiolucent structure within the gastric antrum corresponding to the missing portion of the telescoping dilator. We contacted the on-call gi (gastro-intestinal) doctor for endoscopic retrieval of this foreign body. The patient was taken to or (operating room) and had the foreign body successfully removed.
 
Manufacturer Narrative
The actual complaint product was not returned for evaluation. A review of the device history record is in-progress. All information reasonably known as of 10-feb-2022 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. Avanos medical, inc. Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the avanos medical, inc. Complaint database and identified as complaint (b)(4). The device was not returned.
 
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Brand NameINTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR
Type of DeviceDH EF PERC PLACEMENT PRODUCTS
Manufacturer (Section D)
AVANOS MEDICAL INC.
5405 windward parkway
alpharetta GA 30004
Manufacturer (Section G)
AVENT SA DE R.L. DE C.V. (AVENT 1)
circuito industial no.40
colonia obrera
nogales, cp
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key13518955
MDR Text Key289616488
Report Number9611594-2022-00012
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080253
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number98433
Device Catalogue NumberN/A
Device Lot Number30106553
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/11/2022 Patient Sequence Number: 1
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