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

Model Number D134805

Device Problems Partial Blockage (1065); Device Contamination with Body Fluid (2317); High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 10/11/2020

Event Type  Injury  

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 a patient underwent cardiac ablation procedure for atrial fibrillation (afib) with thermocool® smart touch® sf bi-directional navigation catheter and suffered thrombosis requiring unspecified intervention.During a redo afib procedure the thermocool® smart touch® sf bi-directional navigation catheter was intended to be used for both mapping and ablation purposes.However, during the ablation procedure the catheter flushed insufficiently.There was an impedance jump from 110 ohm to about 220 ohm during the ablation.Ablation was stopped immediately, and the catheter was removed from the body.The ablation cable was checked and replaced which did not resolve the issue.Thus when the catheter was changed, the map catheter was able to perform sufficient flushing.Blood clot was found at the catheter tip.The physician used the soundstar catheter to check if there were any effusion, and the procedure was continued and finished with a new thermocool® smart touch® sf bi-directional navigation catheter.Afterwards, the patient got blood clot and had to undergo further procedures to remove it.The procedure was able to continue without any complication reported.There was no report of extended hospitalization.The physician¿s causality pinion was not provided.High impedance is not mdr-reportable.Intermittent or low irrigration is not mdr-reportable.Thrombus on the tip of the catheter is mdr-reportable.Since thrombosis required medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it is mdr-reportable.

Manufacturer Narrative

On 2/23/2021, the product investigation was completed.It was reported that a patient underwent cardiac ablation procedure for atrial fibrillation (afib) with thermocool® smart touch® sf bi-directional navigation catheter and suffered thrombosis requiring unspecified intervention.During a redo afib procedure the thermocool® smart touch® sf bi-directional navigation catheter was intended to be used for both mapping and ablation purposes.However, during the ablation procedure the catheter flushed insufficiently.There was an impedance jump from 110 ohm to about 220 ohm during the ablation.Ablation was stopped immediately, and the catheter was removed from the body.The ablation cable was checked and replaced which did not resolve the issue.Thus when the catheter was changed, the map catheter was able to perform sufficient flushing.Blood clot was found at the catheter tip.The physician used the soundstar catheter to check if there were any effusion, and the procedure was continued and finished with a new thermocool® smart touch® sf bi-directional navigation catheter.Afterwards, the patient got blood clot and had to undergo further procedures to remove it.The procedure was able to continue without any complication reported.There was no report of extended hospitalization.The physician¿s causality pinion was not provided.Device evaluation details: according to pictures provided by customer showing catheter tip was received for analysis, apparently it appears thrombus residues.Customer did not send evidence of irrigation and impedance failure.The physical complaint device was visually inspected and it was found in good conditions.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then, a cool flow pump test was performed and it was found within specifications, the catheter was irrigating correctly, no irrigation issues were observed.Then, irrigation test was performed and it was found within specifications, the catheter was irrigating correctly, no irrigation issues were observed.A manufacturing record evaluation was performed for the finished device [30430221l] number, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the photo provided by the customer.However, the catheter passed specification.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

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

Per internal review from the bwi medical safety officer on (b)(6)2021, the medical device problem code (h6) has been updated to "device contamination with body fluid" due to the char identified at the tip of the catheter.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 11114590
• MDR Text Key: 225073937
• Report Number: 2029046-2021-00001
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30430221L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOUNDSTAR ECO; SOUNDSTAR ECO
• Patient Outcome(s): Required Intervention