MAUDE Adverse Event Report: BIOSENSE WEBSTER INC STOCKERT EP SHUTTLE SYS; SIMILAR DEVICE S7001, PMA # P990071

Catalog Number 39D76X

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2019

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a stockert ep shuttle sys and a self-ablation issue occurred.The generator was still ablating even when the foot pedal was not pressed.Per the physician, the foot pedal was not stuck.The sales representative mentioned this issue occurred once before and the foot pedal was previously changed.The nurse was standing next to the generator and immediately pressed stop.Generator parameters were set to power control mode and power cut off at 35 watts.No remote monitoring technologies or other magnetic systems were in the room besides the carto 3 system.No adverse patient consequences were reported.The observed self-ablation has been assessed as a mdr reportable malfunction.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a stockert ep shuttle sys and a self-ablation issue occurred.The investigational analysis completed on 7/10/2019.The device was evaluated and no error was found.Device performed within specifications.The device was subjected to preventative maintenance, safety, and functional testing.All tests passed.No malfunction was found on device.The device history record (dhr) was reviewed.It was verified that the device was manufactured in accordance with documented specification and procedures.Complaint was not confirmed.Manufacture reference no: (b)(4).

• Brand Name: STOCKERT EP SHUTTLE SYS
• Type of Device: SIMILAR DEVICE S7001, PMA # P990071
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8720501
• MDR Text Key: 150165374
• Report Number: 2029046-2019-03289
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 39D76X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Date Manufacturer Received: 05/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1