BOSTON SCIENTIFIC CORPORATION XENFORM; MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
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Model Number M0068302470 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Urinary Retention (2119); Urinary Tract Infection (2120)
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Event Date 06/18/2014 |
Event Type
Injury
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Manufacturer Narrative
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Study name: u9920 xenform a/a postmarket.The complainant indicated that the device is implanted and the device 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.
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Event Description
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It was reported to boston scientific corporation that a xenform soft tissue repair matrix was implanted during an apical suspension and cystocele repair with xenform procedure performed on (b)(6) 2014.According to the complainant, on (b)(6) 2014, the patient was unable to void after catheter removal.She was discharged with a foley catheter and had a post-operative infection.The catheter was then removed and she was prescribed with antibiotics.Nevertheless, the repair was noted to be healing well.The event of urinary retention resolved on (b)(6) 2014.She has no fevers at present.
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Manufacturer Narrative
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Alternative patient id: (b)(6).
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Event Description
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It was reported to boston scientific corporation that a xenform soft tissue repair matrix was implanted during an apical suspension and cystocele repair with xenform procedure performed on (b)(6) 2014.According to the complainant, on (b)(6) 2014, the patient was unable to void after catheter removal.She was discharged with a foley catheter and had a post-operative infection.The catheter was then removed and she was prescribed with antibiotics.Nevertheless, the repair was noted to be healing well.The event of urinary retention resolved on (b)(6) 2014.She has no fevers at present.
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Event Description
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It was reported to boston scientific corporation that a xenform soft tissue repair matrix was implanted during an apical suspension and cystocele repair with xenform procedure performed on (b)(6) 2014.The patient also underwent a concomitant midline plication, right and left paravaginal defect repair with native tissue, robotic-assisted total laparoscopic hysterectomy, native tissue rectocele repair, and transobturator sling placement.The procedures were completed without complications.According to the complainant, on (b)(6) 2014, following catheter removal, the patient was unable to void and presented a lower urinary tract infection but no fevers.On (b)(6) 2014, the patient was again unable to void and she was discharged with a foley catheter and was prescribed levaquin for her urinary tract infection.Both events resolved on (b)(6) 2014.The investigator assessed the event of difficulty emptying bladder as moderate in severity, pelvic floor related, probably related to the procedure, and probably related to the device.The lower urinary tract infection was assessed by the investigator as moderate in severity, not related to the pelvic floor, possibly related to the procedure, and not related to the device.Repair was noted to be healing well.
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Manufacturer Narrative
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Block a1: alternative patient id: (b)(6).Blocks f10 and h6: patient codes 2119 and 2120 capture the reportable events of difficulty emptying the bladder and lower urinary tract infection.Block g3: study name: u9920 xenform a/a postmarket.Block h6: conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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.
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