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 Problem Unspecified Infection (1930)

Event Date 08/24/2015

Event Type  Injury  

Manufacturer Narrative

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 Description

It was reported to boston scientific corporation that a xenform soft tissue repair matrix was used during pelvic floor reconstruction with apical vault suspension including cystocele repair procedure performed on (b)(6) 2015.According to the complainant, on (b)(6) 2015, the patient experienced bladder infection and was treated with augmentin.The event resolved on (b)(6) 2015.

Event Description

It was reported to boston scientific corporation that a xenform soft tissue repair matrix was used during pelvic floor reconstruction with apical vault suspension including cystocele repair procedure performed on (b)(6) 2015.According to the complainant, on (b)(6) 2015, the patient experienced bladder infection and was treated with augmentin.The event resolved on (b)(6) 2015.Additional information received on september 21, 2018.The event of bladder infection has been updated to lower urinary tract infection.

• 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
• MDR Report Key: 6363439
• MDR Text Key: 68465104
• Report Number: 3005099803-2017-00513
• Device Sequence Number: 1
• Product Code: PAJ
• Combination Product (y/n): N
• PMA/PMN Number: K060984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/03/2017

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
• Device Operator: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: M0068302470
• Device Lot Number: 0001502025
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 02/28/2017
• Supplement Dates Manufacturer Received: 09/21/2018
• Supplement Dates FDA Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 80