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); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An examination of the returned capio slim suture capturing device and mesh assembly was performed.The mesh assembly was returned separated into components: (1) the half of the mesh assembly containing the blue/white dilator: the dart and suture were intact.The leader loops were cut.The mesh material was detached; (2) the half of the mesh assembly, corresponding to the blue dilator, was received separated into two components.The protective sleeve was detached.The leader loops were cut.On the blue dilator itself, the dart and suture were intact; (3) on the mesh material itself, signs of use were present.Tool marks were noted on both dilators.Furthermore, on the capio slim suture capturing device, there was no damage noted to the device.The carrier could be extended and retracted into the cage with no issue.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.As the user was able to implant successfully on the left side, it is also likely that the patient's anatomical condition, e.G.Potential scar tissue or bone on the right side, contributed to the reported "failure to penetrate tissue." therefore, the complaint investigation conclusion code selected is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on the event.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was used during an uphold lite procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the device did not penetrate the tissue on the patient's right side.Reportedly, the physician tried several times.The procedure was completed with another uphold lite with capio slim device.There were no patient complications as a result of the event.The patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed reportable based on the investigation results: the mesh material and the protective sleeve were detached.

• 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
• Manufacturer (Section G): FREUDENBERG MEDICAL; 2301 centennial boulevard; jefferson IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8397688
• MDR Text Key: 138079205
• Report Number: 3005099803-2019-00929
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2019

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 Expiration Date: 04/04/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000061420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2017
• 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
• Patient Age: 66 YR
• Patient Weight: 58