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

Model Number M0068318170

Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)

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

Event Date 04/20/2018

Event Type  malfunction  

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 was used during a pelvic floor repair procedure performed on an unknown date.According to the complainant, one side of the mesh has no dart, "making it impossible to connect with the capio and fixing the mesh." all other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Manufacturer Narrative

Updated based on the investigation analysis: the detached dart was found in the capio cage.There was no information available regarding the event date therefore the bsc aware date was used.Problem code 2907 captures the reportable event of dart detachment.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 was performed on both returned capio slim suture capturing device and mesh assembly.There was no damage noted to the capio slim suture capturing device.On the mesh assembly, there was no damage noted to the mesh material itself.The leader loops were intact.On the blue/white dilator, the suture was broken in the area where the dart interacts with the carrier, confirming the complaint.On the blue dilator, no damage was noted; the dart and suture were intact.A functional assessment for the capio slim suture capturing device was performed.No issues were noted with the carrier, or when pulling the lead.The cage of the capio slim suture capturing device was removed for further inspection; the portion of the detached suture containing the dart was found inside of the cage.The investigation conclusion code selected for the dart detachment/suture broken issue is design inadequate for purpose, which indicates that problems were 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 the dart detachment/suture broken issue.That investigation determined the root cause is inadequate design/design controls, as the design of the carrier allows the fiber portion of the suture to interact with the sharp edge of the carrier, resulting in the suture severing.The investigation is in the implementation phase and no further escalation is required.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim was used during a pelvic floor repair procedure performed on an unknown date.According to the complainant, one side of the mesh has no dart, "making it impossible to connect with the capio and fixing the mesh." all other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

• 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: 7525130
• MDR Text Key: 108608589
• Report Number: 3005099803-2018-01460
• 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: 02/26/2019

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: 04/26/2019
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000029299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 01/30/2019
• Supplement Dates FDA Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other