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 UNK166

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The exact age of the patient is unknown, however, it was reported the patient was over 18 years.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The complainant indicated that the device 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.The voluntary user medwatch number is (b)(4).

Event Description

It was reported to boston scientific corporation that a xenform soft tissue repair matrix was used during a vaginal hysterectomy, bilateral salpingectomy, removal of right ovarian lesion, transvaginal removal of synthetic mesh midureteral sling, cystourethroscopy procedure performed on an unknown date.According to the complainant, the patient experienced dyspareunia and pelvic pain on an unknown date after the device was implanted.The mesh was explanted on (b)(6) 2014.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

• 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: 5331507
• MDR Text Key: 34519942
• Report Number: 3005099803-2015-03679
• 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
• Report Date: 12/03/2015

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: Health Professional
• Device Model Number: UNK166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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