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

Model Number M0068201000

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

Patient Problems Incontinence (1928); Prolapse (2475); No Code Available (3191)

Event Date 01/10/2001

Event Type  Injury  

Manufacturer Narrative

This event was reported by the patient's legal representation.The (b)(6) 1997 implant procedure and (b)(6) 2001 procedure were performed by: (b)(6).(b)(4).The complainant indicated that the device is implanted and is not expected to 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 vesica pbns kit was implanted into the patient for the treatment of mixed urinary incontinence during a procedure performed on (b)(6) 1997.As reported by the patient's attorney, the patient underwent implant of an additional sling device (non-bsc) on (b)(6) 2001 due to (recurrent) stress urinary incontinence (sui) and cystocele.Boston scientific has been unable to obtain additional information regarding the event to date.

• 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9832750
• MDR Text Key: 189577847
• Report Number: 3005099803-2020-00955
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2000
• Device Model Number: M0068201000
• Device Catalogue Number: 820-100
• Device Lot Number: 0000656531
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR