MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH XENFORM SOFT TISSUE REPAIR MATRIX; MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO

Model Number M0068302470

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Date 11/19/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was 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 xenform soft tissue repair matrix was used during a pelvic floor repair with xenform including laparoscopically assisted vagina hysterectomy & cystocele repair procedure performed on (b)(6) 2015.According to the complainant, on (b)(6) 2015, the patient experienced urinary tract infection.She was treated with antibiotics and the event resolved on (b)(6) 2015.

Manufacturer Narrative

(b)(4).This patient was also reported under mfr report 3005099803-2017-01263.The event of urinary tract infection reported under mfr report 3005099803-2015-03587 and any new event information will be sent under mfr report 3005099803-2017-01263.

Event Description

It was reported to boston scientific corporation that a xenform soft tissue repair matrix was used during a pelvic floor repair with xenform including laparoscopically assisted vagina hysterectomy & cystocele repair procedure performed on (b)(6) 2015.According to the complainant, on (b)(6) 2015, the patient experienced urinary tract infection.She was treated with antibiotics and the event resolved on (b)(6) 2015.

• Brand Name: XENFORM SOFT TISSUE REPAIR MATRIX
• Type of Device: MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 5319461
• MDR Text Key: 34146769
• Report Number: 3005099803-2015-03587
• Device Sequence Number: 1
• Product Code: PAJ
• Combination Product (y/n): N
• PMA/PMN Number: K060984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

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?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2017
• Device Model Number: M0068302470
• Device Lot Number: 0001504063
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: 09/19/2018
• Supplement Dates FDA Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR