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

Catalog Number	CAL-DS01BOV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Urinary Retention (2119); Obstruction/Occlusion (2422)
Date of Event	12/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dr.(b)(6) expressed that she don't feel that the products are defective, she feels that she is less effective with this particular sling.As this involves patient adverse events of retention, it will be submitted as an mdr.The lot history record for desara blue ov # h03006 shows no non-conformances or deviations that could have caused or contributed to this incident.The product was used prior to its expiration date of 04-24-2020.As per the product ifu #10-139-03, voiding dysfunction and obstruction due to placing too much tension to the mesh implant are known adverse reactions as indicated in the adverse reactions section of the ifu.To prevent this, surgeons are advised to place the sling in a tension free manner as indicated in the surgical techniques sections of the ifu.
Event or Problem Description
On 06/26/19 sales rep reports: "one of my surgeons (dr.(b)(6) at the (b)(6) clinic) told me about a few issues this morning that have caused her to switch back to ethicon.She has been using desara blue and desara blue tv for about 4 months now.She had an "obstruction" with two patients using the tot approach.She also had to put a third patient back under anesthesia because of pelvic pain after she implanted our sling.She mentioned that she went back in and it looked like it had completely curled into itself.It sounds to me like she's tensioning it too tightly, which makes sense coming from a pre-ethicon user.I prepped her on tensioning before she started using caldera, but maybe she's still tensioning too tight, causing it to curl.She also made a comment in the past about how our mesh looks like it was not heat-treated in the middle on the top and bottom edge because the mesh looked frayed.This is all of the information i was able to get, as she was in the middle of a hysterectomy when she told me about these experiences." additional information has been requested from sales rep and surgeon including details, treatment, and lot number associated with issue.On 07/09/2019, dr.(b)(6) reports: "there was nothing "wrong" with the slings that i observed when placing them.It is unusual to obstruct a patient with a transobturator sling.I have never had this happen before until i was using the desara to approach.I don't feel that the products are defective, it may be that i am less effective with this particular sling." per dr.(b)(6), the dates of the incidents are as follows: (b)(6) 2018 at (b)(6), (b)(6) 2019 at (b)(6) hospital.Lot # for desara blue ov is h03006.Urinary retention sling removal (cal-ds01bov) was completed on (b)(6) 2019.Incomplete bladder emptying sling removal (desara blue tv) was completed on (b)(6) 2019.This submission is mdr 1 of the 3 reported adverse events of obstruction and retention.

• Brand Name: DESARA BLUE OV
• Common Device Name: PELVIC MESH
• Manufacturer (Section D): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hills CA 91301
• MDR Report Key: 8798094
• Report Number: 3003990090-2019-01481
• Device Sequence Number: 19634807
• Product Code: OTN
• UDI-Device Identifier: 00890594000681
• UDI-Public: 00890594000681
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K1326069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2019

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: Health Professional
• Device Expiration Date: 04/24/2020
• Device Catalogue Number: CAL-DS01BOV
• Device Lot Number: H03006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/17/2019
• 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: Hospitalization; Required Intervention