MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1318-02-S

Device Problems Charred (1086); Low impedance (2285)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2014

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, there was no issues were observed while ablating in the left atrium.Upon completion, the catheter was pulled to the right and mapping of the cti (cavo tricuspid isthmus) began.The impedance issue was observed while abating across the cti to resolve right atrial flutter.The physician also observed a low impedance of approximately 60 ohms and consistent tip temperature of 39 to 40 c displaying on stockert remote interface.The stockert was switched off-on without any resolution.This was thought possibly positional since the anatomy revealed a deep pouch.There was a gradual rise in impedance when this catheter was in use.The catheter was stable during respiration and apnea.The impedance began at base line approximating 90-110 ohms.The impedance steadily increased over base line with a steepening rise of 10-30 ohms within 30 seconds.The rf was immediately terminated as this was observed thus; the maximal cut-off delta was not triggered.The physician observed impedance rise via the rf graphic interface on bard and carto.Upon removing the device, there was a char on the tip of catheter.The device was flushed at 60 ml/min and reinserted.The impedance rose again and the device was removed a second time.It has char on the tip and it appeared occluded.The catheter was again flushed at 60 ml/min.The ablation cable and stockert to communication unit cables were replaced without any resolution.Finally, the catheter was replaced and no further issues were observed when ablating along the entirety of the cti including pouch.The case resumed and was completed without any patient consequence.The stockert setting was 30-40 watts, temperature: 43c and temperature control mode and standard delta cut-off was 200 ohms.There was no error or warning messages.The flow rate when the event occurred was 15 ml/min and with 2 ml/min in low flow.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Manufacturer ref # (b)(4).It was reported that there was a gradual rise in impedance when the catheter was in use.Upon removing the device, there was char on the tip.The device was flushed and reinserted.The impedance rose again and the device was removed a second time.It had char on the tip and it appeared occluded.The returned device was visually inspected upon receipt and it was found in normal conditions.No char was found.Per the event, the catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.In addition, an irrigation test was performed and catheter passed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint cannot be confirmed.

• Brand Name: THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3746287
• MDR Text Key: 4418596
• Report Number: 9673241-2014-00142
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S034
• 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
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: D-1318-02-S
• Device Catalogue Number: D131802
• Device Lot Number: 16056276L
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1