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

Catalog Number CAL-DS01BTV

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Bowel Perforation (2668)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

The risk of bladder/organ perforation is a known potential adverse event and is listed in the adverse reactions section of the desara blue tv product ifu #10-139-06.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

The surgeon perforated the bladder to the extent where mesh entered the bladder, the sling had to be removed and the procedure could not be completed.Surgeon suspected that he may not have displaced the bladder far enough with a catheter to avoid perforating the bladder with the instrument.

• Brand Name: DESARA BLUE TV
• Type of Device: PELVIC MESH
• Manufacturer (Section D): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hill, ca
• Manufacturer (Section G): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hills, ca
• Manufacturer Contact: ieva sirokoviene ; 5171 clareton drive; agoura hills, ca ; 4837641
• MDR Report Key: 10460409
• MDR Text Key: 204569951
• Report Number: 3003990090-2020-01505
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00890594000834
• UDI-Public: 00890594000834
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162201
• 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: 08/27/2020

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: No Information
• Device Expiration Date: 12/04/2022
• Device Catalogue Number: CAL-DS01BTV
• Device Lot Number: K12002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2019
• 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