MAUDE Adverse Event Report: BIOSENSE WEBSTER INC STOCKERT 70 SYSTEM; RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE

Catalog Number S7001

Device Problems High impedance (1291); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2017

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.This stockert was manufactured before september 24, 2014, therefore no udi is applicable for this product with (b)(4).

Event Description

It was reported that a patient underwent an atrial flutter procedure with a stockert 70 system and a high impedance occurred.During the procedure, the impedance readings were irregular.In addition, the temperature decreased while on ablation.The grounding pad and cables were replaced without resolution.The unit was replaced and the issue resolve.The stockert was in power control mode with setting for a smarttouch sf catheter.The stockert was connected to both a smarttouch sf catheter and a carto 3 system.Temperature cutoff was 43°c and would only reach 35°c during ablation and then would decrease to 25°c.The temperature would not stay at a steady rate.The power was at 30 watts and would increase incrementally to 35-40 watts.The impedance would on occasion jump from 150-200 ohms and the catheter was nowhere near the coronary sinus.The impedance cut off was 180 ohms and the impedance would rise to 210 ohms and the generator would keep ablating.Ablation was stopped only by using the stop button when the impedance would go over the cutoff value.The procedure was completed with no patient consequence.The temperature issue is not mdr reportable because the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.However, the impedance issue is mdr reportable.If the generator reads impedance higher than the impedance cutoff value and the generator did not stop the ablation, this can cause a potential risk to the patient.

Manufacturer Narrative

It was reported that a patient underwent an atrial flutter procedure with a stockert 70 system and a high impedance occurred.During the procedure, the impedance readings were irregular.In addition, the temperature decreased while on ablation.The device was evaluated and no error was found.Device was within specification.The device was subjected to preventative maintenance, safety and functional testing and all tests passed.No malfunction was found on the device.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on october 1, 2018.The device history record review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer's ref.No: (b)(4).

• Brand Name: STOCKERT 70 SYSTEM
• Type of Device: RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 6996458
• MDR Text Key: 91926649
• Report Number: 2029046-2017-01090
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S7001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1