MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 820-130

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

Patient Problem Insufficient Information (4580)

Event Date 03/30/2004

Event Type  Injury  

Manufacturer Narrative

The exact event onset date is unknown.The provided event date of (b)(6) 2004 was chosen as a best estimate based on the date of the implant surgery.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implanting surgeon is dr.(b)(6).(b)(6) hospital.(b)(4).

Event Description

It was reported to boston scientific corporation that a vesica press-in kit was used to secure a facial sling implanted into the patient during a cystoscopy, suprapubic tube placement, and pubovaginal sling procedures performed on (b)(6) 2004 for the treatment of stress urinary incontinence.The patient tolerated the implant procedure well and was taken to the recovery room in stable condition.As reported by the patient's attorney, the patient experienced an unspecified injury.

• Brand Name: BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15946638
• MDR Text Key: 305135480
• Report Number: 3005099803-2022-06893
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2006
• Device Model Number: 820-130
• Device Catalogue Number: 820-130
• Device Lot Number: 0005888273
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2003
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female