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 Retention (2119)
Date of Event	04/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Study name: (b)(6).The complainant indicated that the device is 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 or Problem Description
It was reported to boston scientific corporation that a xenform soft tissue repair matrix device was implanted during a pelvic floor reconstruction with xenform including apical vault suspension and cystocele repair procedure performed on (b)(6) 2014.According to the complainant, on (b)(6) 2017, the patient experienced difficulty emptying her bladder.No treatment was given and the event has not yet resolved.

• 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: 6739242
• Report Number: 3005099803-2017-02128
• Device Sequence Number: 11079496
• Product Code: PAJ
• UDI-Device Identifier: 08714729774198
• UDI-Public: (01)08714729774198(17)20161231(10)0001402016
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K060984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2017

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: 12/31/2016
• Device Model Number: M0068302470
• Device Lot Number: 0001402016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 07/24/2017
• 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: Other
• Patient Age: 61 YR
• Patient Weight: 58