MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD? LITE; MESH, SURGICAL, SYNTHETIC

Model Number M0068318170

Device Problems Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

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

Event Date 05/13/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an uphold (tm) lite w/ capio slim was used during an anterior vaginal repair procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the capio device would deploy at a slight angle.Due to this the device cage could not catch the needle.The procedure was completed with another of the same device.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.This event has been deemed reportable based on investigation results finding the dart and distal end of one of the sutures on the mesh assembly to be missing and not returned.

Manufacturer Narrative

The patient's age is unknown; however the patient was over 18 years of age.Reported event: needle detached.Evaluation of the returned capio device found that the carrier is bent and does not deploy into the center of the catch.Visual evaluation of the returned mesh assembly found the suture on one dilator broken with 1.5 cm of the suture still attached and approximately 3.5 cm of suture and dart missing and not returned.Attempts to obtain information regarding the missing needle and its location have been unsuccessful.Review and analysis of all available information indicated the most probable root cause for the event of 'capio device would deploy at a slight angle' was design.A root cause for the event of 'mesh assembly - needle detached and was not returned' could not be determined.The device history record review found the device met all manufacturing specifications.

• Brand Name: UPHOLD? LITE
• Type of Device: MESH, SURGICAL, SYNTHETIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): MEDVENTURE TECHNOLOGY CORPORATION; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4034818
• MDR Text Key: 4882226
• Report Number: 3005099803-2014-02936
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2017
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: ML00002068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2014
• 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