MAUDE Adverse Event Report: AVANOS MEDICAL INC. AVANOS CURVED SHARP RF CANNULA, RADIOPAQUE MARKER; STANDARD RF PROBES AND CANNULAS

Model Number PMF20-100-10CS

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record is in-progress.The sample is reported to be available, but has not yet been received by the manufacturer.All information reasonably known as of (b)(6) 2021 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.

Event Description

It was reported that the radiopaque portion of the cannula broke off during the procedure and embedded into the soft tissue of the cervical region.Additional information received 29-dec-2020 from the physician indicated "radiopaque indicator at the base of the active tip was noted to be disengaged from the cannula during placement/manipulation of the tip to get it in the right position.The stylet was engaged during manipulation.Radiopaque dot could be seen on x-ray during the procedure that was left behind along the lateral cervical waist." component reported to still be in patient.Additional information has been requested but not yet received.

Manufacturer Narrative

The device history record for lot 20042519 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 24 mar 2021 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: AVANOS CURVED SHARP RF CANNULA, RADIOPAQUE MARKER
• Type of Device: STANDARD RF PROBES AND CANNULAS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11154981
• MDR Text Key: 226564496
• Report Number: 8030647-2021-00001
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 00193493986347
• UDI-Public: 00193493986347
• Combination Product (y/n): N
• PMA/PMN Number: K972846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PMF20-100-10CS
• Device Catalogue Number: N/A
• Device Lot Number: 20042519
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2021
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 69