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

Model Number M0068318170

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2018

Event Type  malfunction  

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 lite with capio slim device was used during an anterior repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the capio carrier failed to retract after the black plunger was actuated and it had to be manually pulled for it to retract.The procedure was completed with another of the same capio slim device and with the same uphold mesh assembly from the kit.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Problem code 1536 captures the reportable event of carrier retraction problem.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.A visual examination of the returned capio slim device revealed no damage.Functional analysis revealed that the carrier could be retracted and extended with no issue.The device functioned as intended.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.Based on the information available and the analysis performed, the most probable cause for the complaint event is no problem detected, which indicates that the device complaint or problem cannot be confirmed as there were no issues noted with the returned device.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was used during an anterior repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the capio carrier failed to retract after the black plunger was actuated and it had to be manually pulled for it to retract.The procedure was completed with another of the same capio slim device and with the same uphold mesh assembly from the kit.There were no patient complications reported as a result of this event.

• 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: 8026997
• MDR Text Key: 125770113
• Report Number: 3005099803-2018-61106
• 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: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 72441
• Device Lot Number: 0000054929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1