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	M0068302450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	12/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complete patient id is (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 tissue repair matrix was used during a pelvic floor reconstruction with xenform including vaginal approach hysteropexy and cystocele repair procedure performed on (b)(6) 2016.According to the complainant, on (b)(6) 2016, the patient experienced urinary retention.No treatment was given and the event is currently resolving.
Additional Manufacturer Narrative
Outcomes attributed to adverse event: updated.
Event or Problem Description
It was reported to boston scientific corporation that a xenform tissue repair matrix was used during a pelvic floor reconstruction with xenform including vaginal approach hysteropexy and cystocele repair procedure performed on (b)(6) 2016.According to the complainant, on (b)(6) 2016, the patient experienced urinary retention.No treatment was given and the event is currently resolving.Additional information received on august 21, 2018: the difficulty emptying bladder experienced on (b)(6) 2016 was treated with catheterization and resolved on (b)(6) 2017.

• 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: 6571520
• Report Number: 3005099803-2017-01346
• Device Sequence Number: 16416269
• Product Code: PAJ
• UDI-Device Identifier: 08714729773764
• UDI-Public: (01)08714729773764(17)20160930(10)0001404013
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K060984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/30/2016
• Device Model Number: M0068302450
• Device Catalogue Number: 830-245
• Device Lot Number: 0001404013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 05/17/2017
• Supplement Report FDA Received Date: 09/14/2018
• 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: Other; Required Intervention
• Patient Age: 30 YR
• Patient Weight: 67