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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/24/2018
Event Type  Injury  
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The voluntary user medwatch number is mw5080611.The complainant indicated that the device is not available 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 that a lynx system was used during total vaginal hysterectomy, bilateral salpingo-oophorectomy, anterior repair, posterior repair, tension-free vaginal tape placement for mid-urethral sling, cystoscopy procedure performed on (b)(6) 2018.According to the complainant, during procedure, the plastic sleeve was inadvertently left in place bilaterally.This was noticed during the patient's post-operative visit.Her vaginal exam revealed a retained sleeve in her right posterior vaginal fornix.Reportedly on (b)(6) 2018, the patient was seen for her second post-operative visit and was required surgical removal of the retained sheath.It was reported that during this second post-operative visit, it was discovered that the left sleeve had also been retained and was visible on the left side underneath mid-urethra.No further surgery required as the sleeve could be removed by gently pulling it out.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
 
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.The correct problem code is 1670 which captures the reportable event of use of device problem.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.The voluntary user medwatch number is mw5080611.The complainant indicated that the device is not available 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 that a lynx system was used during total vaginal hysterectomy, bilateral salpingo-oophorectomy, anterior repair, posterior repair, tension-free vaginal tape placement for mid-urethral sling, cystoscopy procedure performed on (b)(6) 2018.According to the complainant, during procedure, the plastic sleeve was inadvertently left in place bilaterally.This was noticed during the patient's post-operative visit.Her vaginal exam revealed a retained sleeve in her right posterior vaginal fornix.Reportedly on (b)(6) 2018, the patient was seen for her second post-operative visit and was required surgical removal of the retained sheath.It was reported that during this second post-operative visit, it was discovered that the left sleeve had also been retained and was visible on the left side underneath mid-urethra.No further surgery required as the sleeve could be removed by gently pulling it out.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
 
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Brand Name
LYNX SYSTEM
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8126929
MDR Text Key129150334
Report Number3005099803-2018-61630
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
PMA/PMN Number
K020110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/03/2019
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/06/2018
Initial Date FDA Received12/03/2018
Supplement Dates Manufacturer Received12/06/2018
Supplement Dates FDA Received01/03/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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