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

Model Number M0068318170

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

(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 a pelvic floor repair procedure performed on (b)(6) 2019.According to the complainant, during deployment of the device during the procedure, the dart separated from the suture inside the patient.The procedure was reportedly completed with another device.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. it is unknown if the detached dart was removed from the patient and/or how it was removed from the patient.Should additional relevant details become available, a supplemental report will be submitted.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was used during a pelvic floor repair procedure performed on (b)(6) 2019.According to the complainant, during deployment of the device during the procedure, the dart separated cleanly from the suture on the patient's right side.Reportedly, the dart was not retrieved from the patient.The procedure was completed with another of the uphold lite with capio slim device.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

Problem codes of 2907 and 3165 capture the reportable event of detached dart remained inside the patient.Manufacturing site: although the current 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.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.The complainant indicated that the device is implanted and the device is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 8390223
• MDR Text Key: 137820373
• Report Number: 3005099803-2019-01011
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• 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: 0000061421
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other