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

Catalog Number CAL-DS01SL

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Bowel Perforation (2668)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

Sales rep and surgeon were contacted for further information.In addition, the msl for this region was notified so that she could follow up directly with the surgeon on procedural/technique improvements.On 06/11/2018: sales rep reports that the sling used was cal-ds01sl and that it was the surgeon's first time using this particular product.The surgeon was able to pass the instrument and sling and no further corrective surgery or hospitalization was required.Since the incident, the surgeon has used this device 3-4 times and has not had an issue other than feeling that she needs to apply more pressure than usual to pass through.No further information has been received and the product was not returned for investigation as it was successfully implanted in the patient.Lot numbers for the instruments or implant used have been reported.The risk of bladder/organ perforation is a known potential adverse event and is listed in the adverse reactions section of the desara sl product ifu #10-222.When cmi devices are used as directed per the product ifu and intended use, the benefit to the patient for the treatment of stress urinary incontinence outweighs this risk.

Event Description

Sales rep reported that an adverse event using caldera medical desara sl sling.The surgeon is a long time abbrevo user.Her instant feedback was that cmi instruments are no where near as sharp as abrevvo's.The rep states that she could see the physician physically strain to push through the obturator.She notes that in one instance, the surgeon needed the help of her fellow to get enough pressure.During this case the surgeon also punctured the bladder 4 times in her first case before she made a successful pass.The sales rep and surgeon were contacted for further information.In addition, the medical science liaison for this region was notified so that she could follow up directly with the surgeon on procedural/technique improvements.Lot numbers were not available for the devices used and instrument type used is unknown.Sales rep reports that the sling used was cal-ds01sl and that it was the surgeon's first time using this particular product.The surgeon was able to pass the instrument and sling and no further corrective surgery or hospitalization was required.Since the incident, the surgeon has used this device 3-4 times and has not had an issue other than feeling that she needs to apply more pressure than usual to pass through.

• Brand Name: DESARA SL
• Type of Device: PELVIC MESH
• Manufacturer (Section D): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hill 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: 7630489
• MDR Text Key: 112078482
• Report Number: 3003990090-2018-01444
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121928
• 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: 06/22/2018

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: Physician
• Device Catalogue Number: CAL-DS01SL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization