MAUDE Adverse Event Report: PROXIMATE CONCEPTS LLC. INPLANT FUNNEL; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Device Problem Product Quality Problem (1506)

Patient Problems Erythema (1840); Fluid Discharge (2686); Breast Discomfort/Pain (4504)

Event Date 02/03/2022

Event Type  malfunction  

Event Description

This patient underwent breast augmentation on (b)(6) 2022 and then presented to the clinic on (b)(6) 2022 with a red, hot breast that was painful, she was started on antibiotics but despite this, started having drainage.During this time, i serendipitously overheard a conversation amongst colleagues that they had noted several implant exposures after using the "inplant funnel." i typically use a "keller implant funnel" but had to used the competing inplant device due to a backorder in this patient's case.The reason why this conversation was important is because i thought my patient had an infection and in cases of implant infection, i remove the implant and leave it out for 3 months before replacement which is a real drag for the patient.My colleagues believed the issue was likely the lubricant used in the inplant funnels as they had had success in their exposure cases by simply washing the pocket out with large volumes of saline and then immediately replacing the implant.Based on this information, i decided to try a large washout with immediate replacement (something i would not do in an infection).This washout procedure was performed on (b)(6) 2022 and was successful - the patient went on to heal without further issues.An important additional note is that i used the inplant funnel for several months at the beginning of 2020 as there was a manufacturing issue and keller funnels were temporarily unavailable at that time.During this time i had 3 augmentations ((b)(6) 2020, (b)(6) 2020, (b)(6) 2020) have implant exposures requiring return to the operating room.There was also a threatened exposure in a case done on (b)(6) 2022 but this went on to heal without needing addition surgery.As a result of seeing so many implant complications in such a short period of time, i became hypervigilant and changed everything about my implant placement technique and the exposures completely stopped happening - i never made the connection that during the time of these exposures i was using a different funnel and then they stopped when the keller funnel came back.Now looking back over all of my implant cases since starting practice 5 years ago, i have had 4 exposures and all 4 occurred during the short stretches of time i was using the inplant funnel (excluding reconstruction cases where the patients received radiation).Finally, i also noted when looking back through my records that all the exposures occurred on the side that received the implant first (i use the same funnel for both sides).This is subjective evidence but is consistent with the idea that the inplant funnel lubricant might be pro-inflammatory as much of the lubricant is wiped away by the implant as it passes through leaving less residual lubricant when the second implant gets placed.Again this is all subjective but i have had 4 exposures out of hundreds of cases over the last 5 years and all 4 of those have occurred during the short periods of time that keller funnels were unavailable and i had to use the inplant funnel.I think it is important for patient safety (all patients went on to heal fine but did require a second trip to the operating room) that this issue be investigated and the lubricant in the inplant funnels should likely be reformulated.Fda safety report id # (b)(4).

• Brand Name: INPLANT FUNNEL
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): PROXIMATE CONCEPTS LLC.; allendale NJ 07401
• MDR Report Key: 14337036
• MDR Text Key: 291358035
• Report Number: MW5109593
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White