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

Model Number M0068318170

Device Problem Detachment Of Device Component (1104)

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

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.(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an uphold¿ lite w/ capio slim was used during a pelvic floor reconstruction with uphold lite procedure.According to the complainant, during the procedure, the dart of the mesh broke off.The procedure was completed with another uphold¿ lite w/ capio slim.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Manufactured and expiration dates are unknown.

Event Description

It was reported to boston scientific corporation that an uphold lite w/ capio slim was used during a pelvic floor reconstruction with uphold lite procedure.According to the complainant, during the procedure, the dart of the mesh broke off.The procedure was completed with another uphold lite w/capio slim.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.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 - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7394002
• MDR Text Key: 104226704
• Report Number: 3005099803-2018-00843
• Device Sequence Number: 1
• Product Code: OTP
• 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,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2019
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other