MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068318170

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(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

T was reported to boston scientific corporation that an uphold lite with capio slim device was used during a pelvic floor repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the dart detached from the suture on the patient's right side.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.There is no information if the detached piece was removed from the patient and if so, how it was removed.The procedure was completed with another uphold lite with capio slim.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 stable.Should additional relevant details become available, a supplemental report will be submitted.

• 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8301897
• MDR Text Key: 134895829
• Report Number: 3005099803-2019-00381
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 02/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other