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

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 The tube was then successfully placed through the peel-away sheath which was then peeled and withdrawn.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.

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR
• Type of Device: DH 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 Key: 13518955
• MDR Text Key: 289616488
• Report Number: 9611594-2022-00012
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080253
• Number of Events Reported: 1
• 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 Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 98433
• Device Catalogue Number: N/A
• Device Lot Number: 30106553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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