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 Device Embedded In Tissue or Plaque (3165)

Event Date 03/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been received for analysis.Upon 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

This report pertains to one of two devices used during the same procedure.Refer to manufacturer report #3005099803-2018-01060 for the other associated device information.It was reported to boston scientific corporation that two uphold lite with capio slim devices were used during a sacrospinous ligament fixation procedure performed on (b)(6) 2018.According to the complainant, for the first device [mfr report #3005099803-2018-01060], during the procedure, the dart detached from the suture while the mesh leg was being placed.The dart was left inside the patient.A second uphold lite with capio slim was used [mfr report #3005099803-2018-01119]; however, after several times of attempting to deploy the dart into the capio cage, the capio carrier broke off.The carrier was removed from inside the patient by hand.There were no patient complications reported as a result of these events.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

A visual examination of the returned dart with small amount of suture confirms the event.Analysis reveals no damage to the capio slim suture capturing device; the device functions as intended.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.However, the assigned complaint investigation conclusion code for this event is manufacturing process design because the design or validation of the manufacturing process was not sufficient to ensure the finished device met the intent of the design.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

This report pertains to one of two devices used during the same procedure.Refer to manufacturer report #3005099803-2018-01060 for the other associated device information.It was reported to boston scientific corporation that two uphold lite with capio slim devices were used during a sacrospinous ligament fixation procedure performed on (b)(6) 2018.According to the complainant, for the first device [mfr report #3005099803-2018-01060], during the procedure, the dart detached from the suture while the mesh leg was being placed.The dart was left inside the patient.A second uphold lite with capio slim was used [mfr report #3005099803-2018-01119]; however, after several times of attempting to deploy the dart into the capio cage, the capio carrier broke off.The carrier was removed from inside the patient by hand.There were no patient complications reported as a result of these events.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

The assigned complaint investigation conclusion code for this event is supplier manufacturing process design, and not manufacturing process design, because the design or validation of the supplier manufacturing process was not sufficient to ensure the finished device met the intent of the design.Block b5 updated to correct the manufacturer report numbers.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report #3005099803-2018-01060 for the other associated device information.It was reported to boston scientific corporation that two uphold lite with capio slim devices were used during a sacrospinous ligament fixation procedure performed on (b)(6) 2018.According to the complainant, for the first device during the procedure, the dart detached from the suture while the mesh leg was being placed.The dart was left inside the patient.A second uphold lite with capio slim was used [mfr report #3005099803-2018-01060]; however, after several times of attempting to deploy the dart into the capio cage, the capio carrier broke off.The carrier was removed from inside the patient by hand.There were no patient complications reported as a result of these events.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
• MDR Report Key: 7444187
• MDR Text Key: 105951989
• Report Number: 3005099803-2018-01119
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2018

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 Expiration Date: 03/26/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000060409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 05/14/2018; 07/19/2018
• Supplement Dates FDA Received: 06/05/2018; 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 60