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

Model Number M0068502110

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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.The 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.

Event Description

It was reported to boston scientific corporation that an advantage fit system was used during a procedure performed on an unknown date.According to the complainant, during unpacking, the blue dilator came off from the device.The procedure was completed with another advantage fit system.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Manufacturer Narrative

An examination of the returned advantage fit system revealed that one blue dilator was separated from the sleeve.The device showed no signs of use or mishandling.The dilator showed minimal signs of bonding in that area which most likely caused the dilator to separate from the sleeve before patient contact, during unpacking.Visual analysis revealed no damage to delivery device.There was no damage to the dilator that was attached to the second sleeve.This dilator deployed from the delivery device as intended.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.However, the investigation concluded that the most probable cause for this event is manufacturing execution error since the condition of the returned device confirms the reported event and the device shows no signs of use or mishandling.An investigation is open to address this issue.

Event Description

It was reported to boston scientific corporation that an advantage fit system was used during a procedure performed on an unknown date.According to the complainant, during unpacking, the blue dilator came off from the device.The procedure was completed with another advantage fit system.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

• Brand Name: ADVANTAGE FIT SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7327514
• MDR Text Key: 102092438
• Report Number: 3005099803-2018-00579
• Device Sequence Number: 1
• Product Code: OTN
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2020
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: 21309081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/27/2017
• 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