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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Alternative patient id: (b)(6).Study name: (b)(6).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.
Event or Problem Description
It was reported to boston scientific corporation that a xenform soft tissue repair matrix was implanted during a pelvic floor reconstruction with xenform including cystocele repair procedure performed on (b)64) 2015.According to the complainant, the patient presented for follow-up on (b)(6) 2015 and there were no signs of infection.However, it was noted that the patient was treated for urinary tract infection on an unknown date.Her post-void residual urine volume was normal but urine was to be sent for culture to check for uti resolution.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

• Brand Name: XENFORM SOFT TISSUE REPAIR MATRIX
• Common Device Name: 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: 7958996
• Report Number: 3005099803-2018-02618
• Device Sequence Number: 19204502
• Product Code: PAJ
• UDI-Device Identifier: 08714729774198
• UDI-Public: 08714729774198
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K060984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: M0068302470
• Device Lot Number: 0001506003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 93