MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problems Insufficient Cooling (1130); Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The smartablate generator displayed a "max temperature" error message, and then the generator cut-off ablation.The catheter was removed from the patient.The caller reported that no char was present on the tip of the catheter.The caller observed that in-between the proximal ring and the ablation electrode, there was a "red tint" present in the irrigation ports.The catheter was replaced and the issue resolved.The procedure continued.The smartablate generator is operating per specs and is not responsible for the product issue.The caller is requesting a replacement catheter.The sheath used was abbott 8.5f sl0.The physician did not feel any resistance while introducing or retracting the catheter from the sheath.The "red tint" was presumed to be blood.No picture but catheter is being returned with red tint still on catheter between ablation tip and proximal poles.High temperature is not mdr-reportable.The foreign material on the usable length of the catheter is mdr-reportable.

Manufacturer Narrative

On (b)(6)-2021, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On (b)(6)-2021, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The smartablate generator displayed a "max temperature" error message, and then the generator cut-off ablation.The catheter was removed from the patient.The caller reported that no char was present on the tip of the catheter.The caller observed that in-between the proximal ring and the ablation electrode, there was a "red tint" present in the irrigation ports.The catheter was replaced and the issue resolved.The procedure continued.The smartablate generator is operating per specs and is not responsible for the product issue.The caller is requesting a replacement catheter.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and generator evaluation of the returned device.Visual analysis of the returned sample revealed reddish material and a hole in the pebax, helix metals are exposed.On the thmcl smtch sf bid catheter.Generator testing and flow pump were performed, in accordance with bwi procedures.The temperature values were observed within specifications.It was irrigating correctly, no irrigation issues were observed.A manufacturing record evaluation was performed for the finished device [30550674m] number, and no internal action related to the reported complaint condition were identified.The evaluation determined that the blood found inside the pebax area could be related to the reported temperature issue.The root cause of the pebax damage cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specifications and procedures.It could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.It should be noted that product failure is multifactorial.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through bwi¿s quality system.No capa activity is required.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12322644
• MDR Text Key: 266657502
• Report Number: 2029046-2021-01344
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30550674M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2021
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 08/29/2021; 09/24/2021
• Supplement Dates FDA Received: 09/20/2021; 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0055-2018
• Patient Sequence Number: 1
• Treatment: ABBOTT 8.5F SL0 SHEATH; CARTO 3 SYSTEM; SMARTABLATE GENERATOR; ABBOTT 8.5F SL0 SHEATH; CARTO 3 SYSTEM; SMARTABLATE GENERATOR