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 Problems Urinary Retention (2119); Urinary Tract Infection (2120); Constipation (3274)

Event Date 03/25/2016

Event Type  Injury  

Manufacturer Narrative

Udi= (b)(4).Patient id is (b)(6).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 tissue repair matrix was used during a pelvic floor repair with xenform including apical vault suspension and cystocele repair procedure performed on (b)(6) 2016.According to the complainant, on (b)(6) 2016, the patient experienced difficulty emptying her bladder.A foley catheter was placed but the event has not yet resolved.On (b)(6) 2016, the patient also experienced urinary tract infection.She was treated with macrobid and the event is currently resolving.

Event Description

It was reported to boston scientific corporation that a xenform tissue repair matrix was used during a pelvic floor repair with xenform including apical vault suspension and cystocele repair procedure performed on (b)(6) 2016.According to the complainant, on (b)(6) 2016, the patient experienced difficulty emptying her bladder.A foley catheter was placed but the event has not yet resolved.On (b)(6) 2016, the patient also experienced urinary tract infection.She was treated with macrobid and the event is currently resolving.Additional information with aware date of april 5, 2016.The event of difficulty emptying bladder has resolved on (b)(6) 2016.The event of urinary tract infection has resolved on (b)(6) 2016.On (b)(6) 2016, the patient experienced constipation.She was admitted to the hospital for less than 24 hours for iv magnesium citrate and the event has resolved on the same day.

• 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
• Manufacturer (Section G): TEI BIOSCIENCES INCORPORATED; 7 elkins street; boston MA 02127
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5596215
• MDR Text Key: 43272640
• Report Number: 3005099803-2016-00980
• Device Sequence Number: 1
• Product Code: PAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2016

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: 08/31/2018
• Device Model Number: M0068302470
• Device Lot Number: 0001512013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 65