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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PINNACLE LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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BOSTON SCIENTIFIC CORPORATION PINNACLE LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN Back to Search Results
Model Number M0068318150
Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/07/2019
Event Type  malfunction  
Manufacturer Narrative
The exact age of the patient is unknown.However, it was reported the patient was over 18 years.(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 a posterior lite with capio slim device was used during a vaginal prolapse with uphold mesh procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when the physician tensioned the mesh through the patient's ligament, the suture detached from the dilator and was then removed from the patient.The physician added that this sometimes happens when the patient has a thick sacrospinous ligament.The procedure was completed with another posterior lite with capio slim device.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.
 
Manufacturer Narrative
The exact age of the patient is unknown.However, it was reported the patient was over 18 years.Problem code 2907 captures the reportable event of suture detachment.An examination of the returned capio slim suture capturing device and mesh assembly was performed.No damage was noted to the capio slim suture capturing device.On the mesh assembly, no damage was noted to the mesh material itself.The leader loops were intact.On the blue/white dilator, no damage was noted; the dart and suture were intact.On the blue dilator, the distal end of the dilator was torn, exposing the suture.The dart and suture were intact.The reported complaint of dart detachment was not confirmed.Furthermore, the carrier extended and retracted into the cage with no issue.The manufacturing batch record review found that the device met its material, assembly and performance specifications at the time of release to distribution.Per investigation, it is possible that the patient anatomy (thick sacrospinous ligament) contributed to the reported complaint.Additionally, it is possible that the excessive force or tensioning was applied, resulting in dilator damage.Hence, the investigation concluded that the most probable cause for this event is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on event.
 
Event Description
It was reported to boston scientific corporation that a posterior lite with capio slim device was used during a vaginal prolapse with uphold mesh procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when the physician tensioned the mesh through the patient's ligament, the suture detached from the dilator and was then removed from the patient.The physician added that this sometimes happens when the patient has a thick sacrospinous ligament.The procedure was completed with another posterior lite with capio slim device.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.
 
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Brand Name
PINNACLE 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 Key8301382
MDR Text Key134880405
Report Number3005099803-2019-00375
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
PMA/PMN Number
K122459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/16/2020
Device Model NumberM0068318150
Device Catalogue Number72440
Device Lot Number0021021770
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2019
Date Manufacturer Received02/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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