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

Catalog Number	CAL-DS01TV
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sales representative was followed up for more information.Surgery prolonged 2-3 min, but the patient was not injured as a result of the incident and the surgery was performed using a new sling.Lot history records for implant indicates no non-conformances or deviations that may have caused or contributed to this incident based upon the reported event.Potential cause for a dilator tube tear or break is excessive force and misuse of the device as it is intended to be used with caldera's tv32 instrument design.Although a dilator tube tear/break may cause a delay in surgery and the waste of an implant, when the product is used as intended and the instrument/implant interface is correctly placed per the product ifu #10-139-06, the overall benefit to the patient outweighs this risk and harm or injury to the patient is mitigated.
Event or Problem Description
Sales representative reports, that dr.(b)(6) during one of her sling implants ran into a user error which lead to an adverse event.Dr.(b)(6) correctly loaded the trocar in the desara tv dilator tube, while she was making her pass, she re-adjusted and pulled the trocar slightly back out but did not realize the dilator tube was not fully extracted with the trocar.Therefore, when dr.(b)(6) made her pass again the trocar tip was not fully through the tube and ended up puncturing through the tube after she exited the abdomen.Dr.(b)(6) could not clamp the dilator tube after the exit through the abdomen because it was bent in the patients needle passage path.The event did not result patient injury and surgery prolong only 2-3 min.Dr.(b)(6) was able to use a new sling and implant successfully.

• 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: 9419678
• Report Number: 3003990090-2019-01492
• Device Sequence Number: 1725196
• Product Code: OTN
• UDI-Device Identifier: 00890594000834
• UDI-Public: 00890594000834
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K1326069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2019

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: No Information
• Device Expiration Date: 07/02/2022
• Device Catalogue Number: CAL-DS01TV
• Device Lot Number: K07002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 12/05/2019
• 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: Required Intervention