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

Model Number 98431

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record for lot 20016171 was reviewed and the product was produced according to product specifications.All information reasonably known as of 16 jun 2020 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.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).

Event Description

Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving the same patient.This is the second of two reports.Refer to 9611594-2020-00101 for the first report.It was reported that the "patient treated for percutaneous gastrostomy.Gastrostomy anchors initially set up without worries.Probe set up without worries.With the withdrawal of the introducer: fall of the anchors.New placement of anchors from a new kit from the same batch with immediate fall from another anchor.3rd attempt with new kit always from the same batch: no problem observed." it was also reported that the patient developed "early pneumoperitoneum in the immediate aftermath.Patient kept hospitalized under surveillance.Need to keep the nasogastric tube and the esogastric [esophagastric] tube in suction for 48 hours.After 2 days without food, the gastrostomy is loaded.No signs of peritoneal irritation or pneumoperitoneum were observed.Patient will be able to return to his home." additional information received 26-may-2020 indicated "the pneumoperitoneum occurred during the procedure and because of successive ruptures of the anchors.They kept the patient under surveillance for 48 hours and the pneumoperitoneum observed developed very well and the patient was able to return home and is doing well.".

Manufacturer Narrative

The device history record for lot 20016171 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 16 jul 2020 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
• Type of Device: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10159115
• MDR Text Key: 199496085
• Report Number: 9611594-2020-00102
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00350770984315
• UDI-Public: 00350770984315
• Combination Product (y/n): N
• PMA/PMN Number: K080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: 98431
• Device Catalogue Number: 109843103
• Device Lot Number: 20016171
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 57