MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH UPSYLON¿; MESH, SURGICAL, SYNTHETIC

Model Number M0068318200

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

The exact age of the patient is unknown.However, it was reported the patient was over 18 years.The lot number does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined, however, it was reported that the device was not used past expiry date.(b)(6).The complainant indicated that the device is implanted and 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.

Event Description

It was reported to boston scientific corporation that an upsylon¿ y-mesh was implanted during a robotic sacrocolpopexy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the mesh torn.According to the operating physician, the mesh was probably cut by the grasper with a blade she was using.Reportedly, it is the same grasper they routinely use.However, during this procedure, the mesh had mild tearing on the side with the grasper.The physician assistant in the procedure reported that the operating physician probably cut a tiny piece of the mesh with the grasper, and then when they pulled on it to tension the mesh to the sacral promontory, it tore further.Subsequently, the they sutured the torn mesh together to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: UPSYLON¿
• Type of Device: MESH, SURGICAL, SYNTHETIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7657472
• MDR Text Key: 112999736
• Report Number: 3005099803-2018-02141
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068318200
• Device Catalogue Number: 831-820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2018
• 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