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

Model Number M0068318170

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Failure to Anastomose (1028)

Event Date 11/19/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Visual examination of the returned uphold lite with capio slim revealed that there was blood residue on the mesh assembly.The suture on the blue with white stripe dilator was broken.There was a tool mark on the suture most likely caused during the removal of the device.The dart was missing and was not returned.Functional analysis showed no damage on the capio slim suture capturing device.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.The review and analysis of all available information fails to indicate a root cause or probable root cause.Therefore, the root cause of this complaint is undeterminable.

Event Description

It was reported to boston scientific corporation that a uphold (tm) lite w/ capio slim was used during a procedure performed on (b)(6) 2015.According to the complainant, during the procedure, "the uphold kit malfunction; insertion release of the needle through the needle".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.This event has been deemed a reportable event based on the investigation results: the suture on the blue with white stripe dilator was broken.The needle was missing and was not returned.

• 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: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5439147
• MDR Text Key: 38287342
• Report Number: 3005099803-2016-00335
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2018
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: ML00003142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2015
• 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