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

Catalog Number CAL-DS01

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2018

Event Type  Injury  

Manufacturer Narrative

According to the complaint, "the person helping cut the sheath right at the exit incision when dr.(b)(6) was tensioning her sling.The sheath was not held on to and was "sucked" back into the incision.Based on the information available, the cause of the reported event described is user error.The surgical technique used by this particular surgeon and assist did not follow caldera desara instructions for use (ifu# 10-139-03 rev b - ref: warning# 6 and #13).This ifu's section "surgical implant technique" specifically instructs the surgeon "cut off the ends of the mesh assembly medial to the tip and suture connection system and pull off the sheath." additionally, the use of this device is restricted to physicians trained in performing sub-urethral sling procedures for treating stress urinary incontinence.Although not intended for long-term use, it appears that the sleeve portion of the mesh previously underwent the same biocompatibility testing as the permanent implant and met the predefined acceptance criteria.It is therefore a low risk material for biocompatibility.No non-conformances or complaints related to the mesh lot j02006 or sleeve lot j01006.Finished device passed all visual tip inspection, sleeve gap inspection, junction test, and mesh test, per lot history record.The subassembly sleeve width passed a sample inspection.Finally, the product was used prior to its expiration date of 02/27/2023.

Event Description

Dr.(b)(6) had an "assist" who was helping her today in her case (dr.(b)(6) wouldn't release if it was a resident or assistant).The person helping her cut the sheath right at the exit incision when dr.(b)(6) was tensioning her sling.The sheath was not held on to and was "sucked" back into the incision.The sheath was not in the patient and could not be retrieved.Dr.(b)(6) removed the placed sling in hopes the sheath would come out, but it didn't.Then surgeon tried to place another sling, by passing the trocar in hopes it would push the sheath out, it didn't.The new sling was taken out of the patient, and dr.(b)(6) called sales rep to discuss this issue.Sales rep mentioned to surgeon the "plastic sheath" would need to be removed from the patient's body.Later surgeon was able to dissect vaginally and pull out the sheath.Per dr.(b)(6), the complaint sling was disposed of after surgery and not available for return.No serious injury to the patient as a result of the procedure.No patient contraindications that could have caused or contributed to the incident.

• Brand Name: DESARA
• Type of Device: PELVIC MESH SLING
• Manufacturer (Section D): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hills CA 91301
• Manufacturer (Section G): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hills CA 91301
• Manufacturer Contact: ieva sirokoviene ; 5171 clareton drive; agoura hills, CA 91301 ; 8184837641
• MDR Report Key: 8723448
• MDR Text Key: 149231215
• Report Number: 3003990090-2018-01454
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00890594000049
• UDI-Public: 00890594000049
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2023
• Device Catalogue Number: CAL-DS01
• Device Lot Number: J02006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other