MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH UPSYLON? Y MESH KIT; GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES

Model Number M0068318220

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

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 02/26/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an upsylon y-mesh kit was used during a robotic sacral colpopexy procedure performed on (b)(6) 2014.According to the complainant, during the implantation of the mesh, the trochar from the robot nicked the iliac vessel causing the patient to bleed.The patient required blood transfusions.The procedure was then completed via open surgery.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.The complainant indicated that the device 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.

• Brand Name: UPSYLON? Y MESH KIT
• Type of Device: GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway
• Manufacturer Contact: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3693713
• MDR Text Key: 19022194
• Report Number: 3005099803-2014-01417
• Device Sequence Number: 1
• Product Code: OHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: M0068318220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 55