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

Model Number M0068318170

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site- although the most recent manufacturing site for uphold lite is boston scientific in (b)(4), the reported lot involved in this complaint was manufactured by: (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 device was used during an anterior prolapse repair with uphold lite procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after deployment of the device on the patient's left side, it was noticed that the dart detached from the suture and the capio carrier broke off.The dart was pulled out using the capio device.Another uphold lite with capio slim was then opened to complete the procedure.However, after the procedure, an x-ray was taken and the detached carrier was found left inside the patient.Subsequently, another procedure was performed and the capio carrier was removed by hand.There was no serious injury reported as a result of the event.The patient's condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was used during an anterior prolapse repair with uphold lite procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after deployment of the device on the patient's left side, it was noticed that the dart detached from the suture and the capio carrier broke off.The dart was pulled out using the capio device.Another uphold lite with capio slim was then opened to complete the procedure.However, after the procedure, an x-ray was taken and the detached carrier was found left inside the patient.Subsequently, another procedure was performed and the capio carrier was removed by hand.There was no serious injury reported as a result of the event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Device code of 2907 captures the reportable events of dart and capio carrier detachment.Patient code 3191 captures the reportable event of surgery to take out the detached carrier.Manufacturing site: although the most recent manufacturing site for uphold lite is boston scientific in spencer in, the reported lot involved in this complaint was manufactured by: freudenberg medical, 2301 centennial boulevard, jefferson in, 47130 usa.A capio slim device e was returned with its carrier detached.Examination of the returned device revealed that the head pieces were slightly separated at the distal end.When the plunger was depressed, what looked like a piece of the nitinol wire protruded from the device.The detached section of the carrier was also returned.The capio cage was removed and the device was opened to locate the end of the carrier.The carrier piece from the device and the returned edges appeared match.The mesh assembly was not returned.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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.However, an investigation determined that material brittleness is the root cause of the carrier breaking as evidenced by the brittle cracks in the material detected in the complaint units.Therefore, that investigation concluded that the most probable cause for this complaint is design inadequate for purpose, which indicates that the problems traced to design/design features of the device that do not support or do interfere with the intended purpose of the device.An investigation was opened to address the failure of "carrier broken.".

• 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: 8619484
• MDR Text Key: 145369074
• Report Number: 3005099803-2019-02485
• 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: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000061422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 55