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

Model Number	98433
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Event or Problem 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and removed with hemostats.The tube was then successfully placed through the peel-away sheath which was then peeled and withdrawn.At this point, the technologist noted that an additional portion of the telescoping dilator was not on the procedure tray we rescanned the patient which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.
Additional 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.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30106553, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 08-apr-2022 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR
• Common Device Name: 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
• Report Number: 9611594-2022-00012
• Device Sequence Number: 5248437
• Product Code: KGC
• UDI-Device Identifier: 00350770984339
• UDI-Public: 00350770984339
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K080253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2022
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Hispanic
• Patient Race: White