MAUDE Adverse Event Report: CALDERA MEDICAL INC. DESARA BLUE TV; PELVIC MESH SLING

Catalog Number	CAL-DS01BTV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Several attempts have been made to obtain additional details of the reported event.Mesh extrusion is a common and well documented event and is identified in product labeling (ifu 10-156-03).Based upon the details presented, it is unknown if the device malfunction as described is a result of the device, surgical procedure or patient history.The lot history record for desara blue tv lot # h10017 shows no non-conformances or deviations that could have caused or contributed to this incident.Suture length, junction test, and tip inspections passed all inspections.The product was used prior to its expiration date of 10-24-2020.For subcomponents blue profax mesh strip lot # h09019 and blue profax finished mesh panel lot # h09005, # h09010 no non-conformances were found.Based upon the information as presented, it is unknown whether the issue as described is related to the device, patient medical history, or surgical technique.Mesh erosion/extrusion is a known risk with the use of all mesh procedures and may be due to device malfunction, surgical procedure, or patient medical history.Extrusion is labeled in the product instructions for use (ifu) warning section.When used correctly as intended, the clinical benefit to the patient for the treatment of stress urinary incontinence outweighs this risk.
Event or Problem Description
Sales rep reported via email that a physician mentioned an adverse outcome on (b)(6) 2018 from vertessa lite and desara blue tv."the patient had an erosion and extrusion." additional information has been requested from surgeon including details, treatment, and lot numbers associated with each issue.Dr.Responded with additional information: "i can try to ask in o.R.If they can look up lot number, i found some info in epic.Date of surgery (b)(6) 2018.Midurethral mesh exposure, midline and to the right side.Using estrogen cream before and after surgery.Treated with estrogen, but very tender and could not tolerate office trim for mesh removal.(b)(6) 2018 sling excision and cystoscopy planned.I will let you know if anything unusual." sales rep provided additional information: "i emailed dr.(b)(6) last night asking for clarification on the vl erosion.She mentioned that to me last week when i saw her but didn't mention it in the email she sent yesterday.She told me the vl was eroding at the apex of the patient's vagina.She mentioned the desara was causing more of a discomfort for the patient's husband during intercourse but led me to believe it was extruding as well.I will let you know what i hear back from her.She used desara blue tv and we are trying to track down the lot number." (see complaint (b)(4) for associated vertessa lite y-mesh).Sales rep also reported: "i never heard from account, but i did hear from customer service the lot numbers we sent them in this time frame.Lot # h10017 (cal-ds01btv).After speaking with the physician again in greater detail, it doesn't appear it was a true extrusion.It was more of a failure.She wasn't willing to speak with anyone in any greater detail.".

• Brand Name: DESARA BLUE TV
• Common Device Name: PELVIC MESH SLING
• Manufacturer (Section D): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hills CA 91301
• MDR Report Key: 8725048
• Report Number: 3003990090-2018-01458
• Device Sequence Number: 11318004
• Product Code: OTN
• UDI-Device Identifier: 00890594000834
• UDI-Public: 00890594000834
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K1326069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2020
• Device Catalogue Number: CAL-DS01BTV
• Device Lot Number: H10017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization