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

Model Number M0068318170

Device Problems Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907)

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

Event Date 07/20/2018

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

It was reported to boston scientific corporation that an uphold (tm) lite with capio slim was used during an uphold lite procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the suture broke after deployment of the capio device.The detached piece was removed from the patient.Reportedly, the suture was not tensioned and was left free hanging during the deployment.In addition, it was also reported that the blue with white stripe dilator bunched up.The procedure was completed with another uphold (tm) lite with capio slim.There are no adverse pt.Effects as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

(b)(4).A visual analysis of the returned uphold lite with capio slim device revealed that the blue with white stripe dilator was buckled and torn.The distal portion of the dilator was broken off and was returned.The suture was broken.The dart was returned attached to the remainder of the suture.The head of the capio slim is slightly separated at the distal end indicating that the user had difficulty during use.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 the most probable code for this event is adverse event related to procedure which indicates that the adverse event occurred during the procedure and the device had no influence on event.

Event Description

It was reported to boston scientific corporation that an uphold (tm) lite with capio slim was used during an uphold lite procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the suture broke after deployment of the capio device.The detached piece was removed from the patient.Reportedly, the suture was not tensioned and was left free hanging during the deployment.In addition, it was also reported that the blue with white stripe dilator bunched up.The procedure was completed with another uphold (tm) lite with capio slim.There are no adverse pt.Effects 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 CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7796391
• MDR Text Key: 117565476
• Report Number: 3005099803-2018-60090
• 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
• Report Date: 11/19/2018

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: 03/12/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 72441
• Device Lot Number: 0000058945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Manufacturer Received: 07/24/2018
• Initial Date FDA Received: 08/20/2018
• Supplement Dates Manufacturer Received: 10/24/2018
• Supplement Dates FDA Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR