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 10/23/2018

Event Type  Injury  

Manufacturer Narrative

As an immediate action, the r&d/eng team provided information with regards to the biocompatibility of the sleeve portion of the mesh.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, which received passing results.It is therefore a low risk material for biocompatibility.However, cmi does not recommend or condone leaving any portion of the sleeve inside the patient.The returned portion of the sleeve/mesh are under investigation by the eng/r&d team.No non-conformance's related to the lot #h10020.Per desara product instructions for use (ifu) #10-139-03, users should note the importance of placing the mesh tension free under the mid-urethra (reference"warnings" section).Additionally, the device is by prescription use and only to be used by physicians trained to implant sui slings.On 11/07/2018: per eng analysis, only a portion of the device was returned, resulting in potential 48mm sleeve portion missing.The rep was contacted to confirm whether or not this portion was thrown away during the surgery.Without confirmation, it is not possible to narrow down whether or not a small piece of the sleeve material remains in the patient as the surgeon initially thought or if this piece was simply thrown out during surgery.Rep was also asked to follow up with surgeon on status of patient post-op.Rep responds that she followed up with the surgeon yesterday and it appears that the patient is doing well with no issues to report and is "recovering normally".Rep also states that a piece may have potentially been thrown away.Additionally, the doctor seems confident that there was no part of the sleeve left in the patient.As this case resulted in a significant delay in surgery, it is being submitted as an mdr.[(b)(4)].

Event Description

Sales rep.(b)(6) called/emailed the corporate team to advise on the following complaint: a portion of desara clear sleeve may have been inadvertently left inside the patient.Due to a unique medical condition with the patient, the surgeon had to "tension the sling much tighter than normal and when she cut the sling, she believes there is a chance that a small piece of sheath tucked back into the suprapubic incision with the sling".During the phone call from the rep and surgeon to corporate, the surgeon asked if it was acceptable to leave the sleeve inside the patient.Cmi informed the surgeon that the sleeve is not intended for long-term use and does not recommend leaving it inside the patient.Per sales rep email (same day), upon evaluation of the remaining portion of the sling, the surgeon and rep did not believe that any portion of the sleeve was left inside of the patient's body.However, the remaining portion of the device was returned to corporate for evaluation.Per eng analysis, only a portion of the device was returned, resulting in potential 48mm sleeve portion missing.The rep was contacted to confirm whether or not this portion was thrown away during the surgery.Without confirmation, it is not possible to narrow down whether or not a small piece of the sleeve material remains in the patient as the surgeon initially thought or if this piece was simply thrown out during surgery.Rep was also asked to follow up with surgeon on status of patient post-op.Rep responds that she followed up with the surgeon yesterday and it appears that the patient is doing well with no issues to report and is "recovering normally".Rep also states that a piece may have potentially been thrown away.However, the doctor seems confident that there was no part of the sleeve left in the patient.As this case resulted in a significant delay in surgery, it is being submitted as an mdr.

• 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: michelle ducca ; 5171 clareton drive; agoura hills, CA 91301 ; 8184837628
• MDR Report Key: 8725169
• MDR Text Key: 149480830
• Report Number: 3003990090-2018-01452
• 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: K132069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/08/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2022
• Device Catalogue Number: CAL-DS01
• Device Lot Number: H10020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2018
• Initial Date FDA Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2018
• 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