MAUDE Adverse Event Report: STOCKERT GMBH STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR; SIMILAR DEVICE S7001, PMA # P990071

Model Number 39D-76X

Device Problems High impedance (1291); Failure to Shut Off (2939)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2015

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.Concomitant products were used during this study: cr3425ct cable, 39e43r cable.(b)(4).

Event Description

It was reported that the impedance reading from ep recording spiked to 4000 when the physician planned to start ablation after mapping in the right atrium during an atrial flutter procedure using a shuttle rf generator (serial number (b)(4)).The impedance cutoff was set to 250 however the generator did not stop delivering rf.The physician was able to stop ablation using the "stop" button on the remote.The procedure was completed successfully without patient consequence.This is reportable as the generator failed to stop ablation once the impedance exceeds cutoff value and thus pose risk to patients.

Manufacturer Narrative

Due to the august 2015 fda maintenance where the 3500a codes were updated, the 3500a codes will be added until the biosense webster system is also updated.Therefore the following codes apply: (b)(4).It was reported that the impedance reading from ep recording spiked to 4000 when the physician planned to start ablation after mapping in the right atrium during an atrial flutter procedure using a shuttle rf generator ((b)(4)).The impedance cutoff was set to 250 however the generator did not stop delivering rf.The physician was able to stop ablation using the ¿stop¿ button on the remote.Repair follow-up was performed and device will not shipped for service.Service was declined.Complaint was unable to confirm.It was informed that device was working fine.The dhr review verifies that the device was manufactured in accordance with documented specification and procedures.

Manufacturer Narrative

This stockert was manufactured before september 24, 2014, therefore no udi is applicable for this product.

• Brand Name: STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR
• Type of Device: SIMILAR DEVICE S7001, PMA # P990071
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• Manufacturer (Section G): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5271504
• MDR Text Key: 33103806
• Report Number: 9612355-2015-00059
• Device Sequence Number: 1
• Product Code: BXN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39D-76X
• Device Catalogue Number: 39D-76X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2003
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1