MAUDE Adverse Event Report: PHYSIQUE; PERMANENT PACING LEAD

Model Number SCREWVINE 52 SEP

Device Problems Difficult or Delayed Positioning (1157); Failure to Advance (2524)

Patient Problem No Information (3190)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

The device model involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.

Event Description

The physician reported that during the implant procedure, the subject lead could not be properly inserted through a 7fr adelante introducer.Reportedly, the lead tip became blocked at the distal end of the introducer.The physician removed the lead and introducer and made an attempt to pass the lead, and it still blocked at the distal opening of the introducer.Another introducer (8fr) was utilized to successfully implant the lead.

Manufacturer Narrative

Please refer to the attached investigation report.

Event Description

The physician reported that during the implant procedure, the subject lead could not be properly inserted through a 7fr adelante introducer.Reportedly, the lead tip became blocked at the distal end of the introducer.The physician removed the lead and introducer and made an attempt to pass the lead, and it still blocked at the distal opening of the introducer.Another introducer (8fr) was utilized to successfully implant the lead.

• Brand Name: PHYSIQUE
• Type of Device: PERMANENT PACING LEAD
• Manufacturer Contact: elodie vincent ; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 6140620
• MDR Text Key: 61602843
• Report Number: 1000165971-2016-00775
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: SCREWVINE 52 SEP
• Device Catalogue Number: SCREWVINE 52 SEP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/01/2016
• Event Location: Hospital
• Date Manufacturer Received: 02/02/2017
• 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