MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068502110

Device Problems Human-Device Interface Problem (2949); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown, however, it was reported that the device was not used past expiry date.(b)(4).The device has not been received for analysis.Upon receipt and 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.

Event Description

It was reported to boston scientific corporation that an advantage fit sling was opened during a mid-urethral sling procedure performed on (b)(6) 2018.According to the complainant, during preparation, when the physician opened an advantage fit sling, the blue dilator split into two pieces.Reportedly, the sling was not used on the patient.The procedure was completed with another advantage fit sling.There were no patient complications reported as a result of the event.The patient's condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown, however, it was reported that the device was not used past expiry date.Problem code 4008 captures the reportable event of dilator torn.A visual examination of the returned mesh assembly was performed.There were no issues noted on the mesh assembly.There was no damage to the dilator tip, dilator, dilator/sleeve joint, protective sleeve, or mesh.In addition, the delivery device was not returned.Therefore, the complaint was not confirmed.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.The investigation concluded that the most probable cause for the dilator torn issue is no problem detected, which indicates that the device complaint or problem cannot be confirmed.

Event Description

It was reported to boston scientific corporation that an advantage fit sling was opened during a mid-urethral sling procedure performed on (b)(6) 2018.According to the complainant, during preparation, when the physician opened an advantage fit sling, the blue dilator split into two pieces and became unsterile.Reportedly, the sling was not used on the patient.In addition, the hospital suggested to have the sleeves over the dilator like obtryx.The procedure was completed with another advantage fit sling.There were no patient complications reported as a result of the event.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: ADVANTAGE FIT SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8133679
• MDR Text Key: 129448767
• Report Number: 3005099803-2018-61722
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• Combination Product (y/n): N
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 01/22/2019
• Supplement Dates FDA Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1