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

Model Number M0068502000

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 08/07/2018

Event Type  malfunction  

Manufacturer Narrative

(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 system device was used during a procedure performed on (b)(6) 2018.According to the complainant, during preparation, upon unpacking the device from the box, the paper seal covering the device was missing.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Manufacturer Narrative

(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 system device was used during a procedure performed on (b)(6) 2018.According to the complainant, during preparation, upon unpacking the device from the box, the paper seal covering the device was missing.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

• Brand Name: ADVANTAGE 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: 7919482
• MDR Text Key: 122158368
• Report Number: 3005099803-2018-60648
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• 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: 10/24/2018

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 Expiration Date: 10/04/2019
• Device Model Number: M0068502000
• Device Catalogue Number: 73176
• Device Lot Number: 0000044727
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 10/07/2018
• Supplement Dates FDA Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1