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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COLPASSIST; MESH, SURGICAL, SYNTHETIC
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BOSTON SCIENTIFIC CORPORATION COLPASSIST; MESH, SURGICAL, SYNTHETIC Back to Search Results
Device Problem Material Split, Cut or Torn (4008)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2018
Event Type  malfunction  
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(6).The complainant indicated that the device is implanted and will not 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.
 
Event Description
It was reported to boston scientific corporation that a y-mesh was implanted during a robotic sacrocolpopexy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, while suturing the y-mesh to the vaginal wall, the physician slightly nicked the mesh.It was a small tear from pulling using the robotic arm.Subsequently, the physician put a suture very close to the small tear to seemingly support the small mesh defect.Reportedly, this procedure was difficult as the patient's anatomy was unique due to a prior abdominal surgery.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Blocks f10 and h6: problem code 4008 captures the reportable event of mesh torn.Block h10: the complainant indicated that the device is implanted and will not 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.Block h11: block d1 has been corrected from "colpassist" to "upsylon".Block e1 has been updated with the initial reporter information.Block h6 has been updated with imdrf f26.
 
Event Description
It was reported to boston scientific corporation that a y-mesh was implanted during a robotic sacrocolpopexy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, while suturing the y-mesh to the vaginal wall, the physician slightly nicked the mesh.It was a small tear from pulling using the robotic arm.Subsequently, the physician put a suture very close to the small tear to seemingly support the small mesh defect.Reportedly, this procedure was difficult as the patient's anatomy was unique due to a prior abdominal surgery.There were no patient complications reported as a result of this event.
 
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Brand Name
COLPASSIST
Type of Device
MESH, SURGICAL, SYNTHETIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
PROXY BIOMEDICAL LIMITED
coilleach, spiddal
galway
EI  
Manufacturer Contact
farshad fahimi
4100 hamline avenue north
building c
saint paul, MN 55112
5086834015
MDR Report Key8217507
MDR Text Key132089392
Report Number3005099803-2018-62442
Device Sequence Number1
Product Code KOH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/30/2024
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/24/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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