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 Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual examination of the returned capio slim suture capturing device was performed.There was residue on the head of the capio device.The head pieces were slightly separated where the metal shaft was enclosed.A functional test was conducted.Plunger was able to be depressed and there was no shaft movement.A small metal piece protruded from the head when the plunger was depressed.The capio head was opened.There was only a small piece of the carrier was identified inside the device.It was then determined that the capio carrier had broken.An investigation was opened to address the failure of "carrier broken." that 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, the investigation concluded that the most probable cause for this failure is design inadequate for purpose indicating 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.

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, the head halves separated.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 and fine.This event has been deemed reportable based on the investigation findings: the carrier broke, and the broken section of the carrier was not returned.It is unknown if the carrier detached inside the patient and if/how the detached carrier was retrieved.Attempts to obtain additional information regarding this event have been unsuccessful to date.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 an anterior prolapse repair with uphold lite procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the head halves separated.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 and fine.This event has been deemed reportable based on the investigation findings: the carrier broke, and the broken section of the carrier was not returned.Please see block h10 for full investigation details.Additional information received on june 18, 2019: the carrier did not break and detach inside the patient.The procedure was completed by suturing by hand without using a capio device.

Manufacturer Narrative

Blocks f10 and h6: device code 2907 captures the reportable event of carrier detachment.Block g1: 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.Block h10: a visual examination of the returned capio slim suture capturing device was performed.There was residue on the head of the capio device.The head pieces were slightly separated where the metal shaft was enclosed.A functional test was conducted.Plunger was able to be depressed and there was no shaft movement.A small metal piece protruded from the head when the plunger was depressed.The capio head was opened.There was only a small piece of the carrier was identified inside the device.It was then determined that the capio carrier had broken.An investigation was opened to address the failure of "carrier broken." that 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, the investigation concluded that the most probable cause for this failure is design inadequate for purpose indicating 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.Block h11: blocks b5, d6, and f10 patient codes updated.

• 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: 8713429
• MDR Text Key: 148460628
• Report Number: 3005099803-2019-02977
• 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: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• 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: 04/25/2019
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 59