MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC UPHOLD LITE

Lot Number ML00001696

Device Problems Break (1069); Failure to Fire (2610)

Patient Problem No Information (3190)

Event Date 12/31/2013

Event Type  Injury  

Event Description

Per physician's operative report, "a horizontal incision was made into the anterior portion of the vaginal wall just below the urethral folds after hydrodissection had been accomplished.This was dissected laterally on either side until reaching the ischial spine, identifying the sacrospinous ligament.Once this had been done, the uphold lite arm was placed on the left without difficulty.The unit would not fire right on the left side and penetrate ligament correctly.A second unit both of the same lot, was tried and it also failed actually the needle broke off outside of the patient and was recovered.Due to this, procedure was abandoned and an elevate anterior was placed.This was placed by placing both arms into the sacrospinous ligaments and the upper anterior arms into the obturator bilaterally.Once this had been done, the tail was trimmed and attached to the 2-0 monocryl suture at the vaginal apex x 2.Good elevation and support was noted once this was pushed down without tension.The locking grommets were placed and the arms were trimmed on both sides.The anterior vaginal wall was then closed with 2-0 monocryl suture in a running continuous fashion." reason for use: vaginal support system used in anterior repair.

• Brand Name: BOSTON SCIENTIFIC UPHOLD LITE
• Type of Device: UPHOLD LITE
• Manufacturer (Section D): BOSTON SCIENTIFIC; jeffersonville IN 47130
• MDR Report Key: 3639490
• MDR Text Key: 4286013
• Report Number: MW5034602
• Device Sequence Number: 2
• Product Code: OTP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/13/2014
• 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: Other
• Device Expiration Date: 08/31/2014
• Device Lot Number: ML00001696
• Other Device ID Number: +ML00001696
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 61