MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP PRECISION SPEEDTAC TRANSVAGINAL ANCHOR SYSTEM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 820-145

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 01/14/2014

Event Type  malfunction  

Event Description

Surgeon performed a cystoscopy, cystocele repair, and pubovaginal sling on this patient.While doing the pubovaginal sling, the surgeon was using a boston scientific precision speedtac transvaginal anchor system and the suture anchor pulled out and would not stay anchored.The circulator opened another boston scientific speedtac transvaginal anchor system and the same thing happened.The third device was opened, boston scientific speedtac transvaginal anchor system, and this one worked without any problems.The patient's diagnosis is stress urinary incontinence and cystocele.This facility has had three of these devices fail during two cases.
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manufacturer response for transvaginal anchor system, precision speedtac (per site reporter).
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sales rep notified - reporter not aware of the response.
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manufacturer response for transvaginal anchor system, precision speedtac (per site reporter).
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sales rep notified - reporter not aware of response.

• Brand Name: PRECISION SPEEDTAC TRANSVAGINAL ANCHOR SYSTEM
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP; one boston scientific place; natick MA 01760
• MDR Report Key: 3624061
• MDR Text Key: 4175411
• Report Number: 3624061
• Device Sequence Number: 2
• Product Code: MBI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/14/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 820-145
• Device Lot Number: 16102828
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 98