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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XENFORM MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO

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BOSTON SCIENTIFIC CORPORATION XENFORM MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO Back to Search Results
Model Number M0068302430
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Micturition Urgency (1871); Scar Tissue (2060); Urinary Retention (2119); Obstruction/Occlusion (2422)
Event Date 04/13/2018
Event Type  Injury  
Manufacturer Narrative
This event was reported by the patient's legal representation. The implanting and sling removal surgeon is: dr. (b)(6), hospital ambulatory surgery. (b)(4). The complainant indicated that the device is implanted and is not expected to 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
Note: this manufacturer report pertains to the third of three devices implanted during the same procedure. It was reported to boston scientific corporation that the patient was diagnosed with lateral cystocele, post hysterectomy vaginal vault prolapse, enterocele, rectocele, urodynamic stress urinary incontinence, weak rectovaginal tissue and ovarian adhesions. On (b)(6) 2017, the patient was implanted with upsylon y-mesh, advantage fit system and xenform devices during a bilateral salpingo-oophorectomy, sacrocolpopexy, enterocele repair, bilateral paravaginal repair, tension-free vaginal tape, urethroscopy, rectocele repair, anal sphincteroplasty, placement of xeno graft due to weak and, friable pelvic floor tissue, lysis of adhesions (loa), vaginal packing due to extensive dissection and oozing and foley placement procedure. On (b)(6) 2018, the patient underwent removal of stress urinary incontinence sling (advantage), urethrolysis and urethrocystoscopy procedure due to irritative obstructive symptoms with urinary retention. During urethrolysis, the physician removed the scar tissue surrounding the urethra and mobilized the urethra through lysis of adhesions to free it up completely. Urethra was then dilated to 10 f dilator. There was no pain or dyspareunia related to the sling. During the revision surgery, it was noted that there was no urethral blockage on the urethra, no abnormality of urethra, bladder neck or trigone, no erosion of the sling material into the urethra or the bladder, and no tumors, stones, foreign bodies or chronic inflammation to explain the patient's urgency. The sling was found to be in mid-urethra and exerting normal tension on the urethra. Urine was effluxing from either ureter without any difficulty in good jet fashion. The patient was reported to be in stable condition after the procedure. There was no apparent untoward event reported.
 
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Brand NameXENFORM
Type of DeviceMESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
TEI BIOSCIENCES INCORPORATED
7 elkins street
boston MA 02127
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key11408953
MDR Text Key234613585
Report Number3005099803-2021-00799
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060984
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 03/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2019
Device Model NumberM0068302430
Device Catalogue Number830-243
Device Lot Number0001705002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/26/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/04/2021 Patient Sequence Number: 1
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