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

Model Number M0068502120

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2022

Event Type  malfunction  

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem 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 blue system device was opened.When the nurse opened the device packaging, she found the sling unsterile.There was no device packaging seal.No further information has been obtained despite good faith efforts.

Event Description

It was reported to boston scientific corporation that an advantage fit blue system device was opened.When the nurse opened the device packaging, she found the sling unsterile.There was no device packaging seal.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: patient code a020503 captures the reportable event of no device packaging seal.Block h10: one advantage fit blue system device was returned for analysis; however, the packaging was not returned.A visual analysis of the returned device was performed and found no problems.Additionally, an image was provided by the customer and attached to the complaint.The image showed the device in an unsealed packaging tray.The rim of the tray appeared to have white glue-like residue.Based on the investigation, the complaint could not be confirmed as the returned device provided insufficient evidence to make any conclusions about the reported complaint, and the photo provided by the customer does not prove that the device was received unsealed by the customer in the reported condition.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.Based on all gathered information, it was determined that given the manufacturing controls in place to prevent this issue, there is insufficient information to conclude that the device was received unsealed by the customer.It is possible that someone at the healthcare facility could have opened the box/carton and removed the seal from the tray, and then placed it back in the carton.Therefore, the cause could not be established.A search of the complaint database confirmed that no similar complaints exist for the specified lot.

• Brand Name: ADVANTAGE FIT BLUE 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14960063
• MDR Text Key: 303912159
• Report Number: 3005099803-2022-03723
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729961925
• UDI-Public: 08714729961925
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

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: M0068502120
• Device Catalogue Number: 73189
• Device Lot Number: 0028875017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2022
• 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