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 Consequences Or Impact To Patient (2199)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

The exact age of the patient is unknown.However, it was reported the patient was over 18 years.(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

It was reported to boston scientific corporation that an uphold¿ lite with capio slim was used during a colpopexy and colporrhaphy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the needle of the capio was ¿released¿ outside the patient.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.

Manufacturer Narrative

A visual examination of the returned uphold lite with capio slim revealed that the darts were not detached from either of the two sutures.Both darts were caught on the cage of the capio slim when actuated.However, the carrier exited the capio slim head slightly bent and then righted itself to the cage which would cause the carrier to stay on a misaligned trajectory during use while going through bodily tissue causing it to miss the cage.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 investigation concluded that this complaint is associated with a product that meets the design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.The most probable root cause classification is operational context.Based on the investigation finding that the neither dart had detached from its respective suture, this is no longer considered a reportable event.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim was used during a colpopexy and colporrhaphy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the needle of the capio was ¿released¿ outside the patient.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.

• 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: 7534279
• MDR Text Key: 108992324
• Report Number: 3005099803-2018-01488
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 04/25/2018

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: 11/07/2019
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000047878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 08/17/2018
• Supplement Dates FDA Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2016
• 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