MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068318170

Device Problems Use of Device Problem (1670); No Apparent Adverse Event (3189)

Patient Problems Urinary Retention (2119); Prolapse (2475)

Event Date 02/25/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, it was reported to boston scientific corporation that an uphold lite with capio slim kit was used during a transvaginal mesh repair procedure with concommitant vaginal cuff suspension performed on (b)(6) 2014 as part of a clinical study.According to the complainant, during the procedure, the capio slim device was not able to capture the ligament correctly.A second capio slim device was opened and used successfully, and the mesh repair was completed with implantation of the uphold lite mesh.No patient complications were reported as a result of the capio slim failure, and the patient's condition at the conclusion of the procedure was reported to be fine.On (b)(6) 2014, it was reported to boston scientific corporation that the patient experienced difficulty emptying her bladder.This was treated with placement of a foley catheter and flomax medication.According to the investigator for the study, the urinary retention was non-serious and related to the procedure.The urinary retention resolved as of (b)(6) 2014, as the patient was able to void without difficulty two hours after removal of the foley catheter.Note: this mfr report on the uphold lite with capio slim kit is being sent due to the urinary retention experienced following the procedure.The failure of the capio slim device to capture the ligament is not considered a reportable event.

Manufacturer Narrative

The capio slim device has been received for investigation.The uphold lite mesh is implanted in the patient.The capio slim device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Visual evaluation of the returned device found that the carrier of the capio slim suturing device was bent.Functional evaluation found that the device failed to catch the needle as reported.The bent carrier is most likely a result of twisting of the capio device within the patient¿s anatomy in order to position the dart properly and the urinary retention is listed in the dfu as a potential adverse event related to the procedure.Thus the review and analysis of all available information indicated the most probable root cause for this event was 'anticipated procedural complication'.The device history record review found the device met all manufacturing specifications.

Event Description

On (b)(6), 2014, it was reported to boston scientific corporation that an uphold lite with capio slim kit was used during a transvaginal mesh repair procedure with concomitant vaginal cuff suspension performed on (b)(6), 2014 as part of a clinical study.According to the complainant, during the procedure, the capio slim device was not able to capture the ligament correctly.A second capio slim device was opened and used successfully, and the mesh repair was completed with implantation of the uphold lite mesh.No patient complications were reported as a result of the capio slim failure, and the patient's condition at the conclusion of the procedure was reported to be fine.On (b)(6), 2014, it was reported to boston scientific corporation that the patient experienced difficulty emptying her bladder.This was treated with placement of a foley catheter and flomax medication.According to the investigator for the study, the urinary retention was non-serious and related to the procedure.The urinary retention resolved as of (b)(6), 2014, as the patient was able to void without difficulty two hours after removal of the foley catheter.Note: this mfr report on the uphold lite with capio slim kit is being sent due to the urinary retention experienced following the procedure.The failure of the capio slim device to capture the ligament is not considered a reportable event.

Event Description

On (b)(6) 2014, it was reported to boston scientific corporation that an uphold lite with capio slim kit was used during a transvaginal mesh repair procedure with concommitant vaginal cuff suspension performed on (b)(6) 2014 as part of a clinical study.According to the complainant, during the procedure, the capio slim device was not able to capture the ligament correctly.A second capio slim device was opened and used successfully, and the mesh repair was completed with implantation of the uphold lite mesh.No patient complications were reported as a result of the capio slim failure, and the patient's condition at the conclusion of the procedure was reported to be fine.On (b)(6) 2014, it was reported to boston scientific corporation that the patient experienced difficulty emptying her bladder.This was treated with placement of a foley catheter and flomax medication.According to the investigator for the study, the urinary retention was non-serious and related to the procedure.The urinary retention resolved as of (b)(6) 2014, as the patient was able to void without difficulty two hours after removal of the foley catheter.Note: this mfr report on the uphold lite with capio slim kit is being sent due to the urinary retention experienced following the procedure.The failure of the capio slim device to capture the ligament is not considered a reportable event.On (b)(6) 2014, the patient experience difficulty emptying her bladder.A foley was placed and the subject discharged home and was prescribed flomax to treat the issue.The subject returned to the clinic to have her foley catheter removed on (b)(6) 2014.She passed her voiding trial by being able to urinate without difficulty 2 hours after the foley catheter was removed.

Manufacturer Narrative

Additional information: blocks a5: race, b5, b7, and h6: patient codes block a1: alternative patient id: (b)(6) block g3: study name: u8090 uphold lite block h6: patient code 2119 captures the reportable event of patient difficulty emptying her bladder.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: visual evaluation of the returned capio slim device found that the carrier was bent.The received mesh assembly was undamaged.Functional evaluation found that the device failed to catch the needle as reported.The bent carrier is most likely a result of twisting of the capio device within the patient's anatomy in order to position the dart properly.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.Additionally, the labeling review found that the reported events of "sensation of bulge" (prolapse) and "patient difficulty emptying her bladder" (urinary retention) were anticipated in the labeling and risk documentation.Therefore, the probable cause for this complaint is known inherent risk of device which indicates that the reported adverse events are known and documented in the labeling (including both short or long term known complications or adverse reactions).

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim kit was used during a pelvic floor repair procedure with uphold lite including apical vault suspension and cystocele repair procedure with concomitant cystocele repair with native tissue, cuff suspension, and removal of pre-existing mesh between anterior vaginal wall and apex performed on (b)(6), 2014 as part of a clinical study.According to the complainant, during the procedure, the capio slim device was not able to capture the ligament correctly.A second capio slim device was opened and used successfully, and the mesh repair was completed with implantation of the uphold lite mesh.No patient complications were reported as a result of the capio slim failure, and the patient's condition at the conclusion of the procedure was reported to be fine.On (b)(6) 2014, the patient experienced difficulty emptying her bladder in relation to the anterior vaginal compartment.A foley catheter was placed and the patient was discharged home and was prescribed flomax to treat the issue.She returned to the clinic to have her foley catheter removed on (b)(6), 2014.She passed her voiding trial by being able to urinate without difficulty 2 hours after the foley catheter was removed.However, the issue did not fully resolve.On (b)(6), 2015, the patient underwent an interstim procedure to treat this event (estim) and the patient is recovering.The investigator assessed the event as mild in severity, not related to the pelvic floor, definitely related to the study procedure, not related to the mesh, and not related to the delivery device.Note: this mfr report on the uphold lite with capio slim kit is being sent due to the urinary retention experienced following the procedure.The failure of the capio slim device to capture the ligament is not considered a reportable event.

• Brand Name: UPHOLD LITE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 3709513
• MDR Text Key: 4246325
• Report Number: 3005099803-2014-01400
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional,Company Representative,company represent
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/19/2020

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: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: ML00001595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2014
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 03/28/2014
• Supplement Dates Manufacturer Received: Not provided; 06/20/2017; 07/23/2020
• Supplement Dates FDA Received: 04/25/2014; 07/13/2017; 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 44