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

Model Number D134805

Device Problems Coagulation in Device or Device Ingredient (1096); Device Contamination with Body Fluid (2317)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2020

Event Type  malfunction  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.We are working on the manufacture record evaluation (mre), once we get more information it will be submitted in the supplemental.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool® smart touch® sf bi-directional navigation catheter, and a thrombus issue occurred.During the procedure, a thrombus was noticed attached to the tip of one of the smart touch sf bidirectional electrodes.The issue was resolved by changing the catheter to another one.The procedure was completed without patient consequences.No further information was provided.The observed thrombus on the electrode has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation on may 18, 2020.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.Per the additional information received on june 8, 2020, processed the d11.Concomitant medical products and therapy dates section.The device evaluation was completed on june 11, 2020.Investigation summary: it was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool® smart touch® sf bi-directional navigation catheter.During the procedure, a thrombus was noticed attached to the tip of one of the smart touch sf bidirectional electrodes.The issue was resolved by changing the catheter to another one.The procedure was completed without patient consequences.The 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.A manufacturing record evaluation was performed and no internal action was found during the review.The customer complaint cannot be confirmed since the device was found working correctly and no evidence of thrombus residues were observed on the catheter.However, the root cause of the thrombus reported by the customer could be related to the usage of the device during the procedure.However, this cannot be conclusively determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

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) initially this event was assessed as mdr reportable for a thrombus issue.During review on (b)(6)2021, a correction was noted to the assessment as this event should have been assessed as char which is not mdr reportable.Char is a physical phenomenon of radio frequency energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.Therefore, updated under ¿h6.Medical device problem code¿ from ¿coagulation in device or device ingredient¿ to ¿device contamination with body fluid¿.

• 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: 10033591
• MDR Text Key: 202237823
• Report Number: 2029046-2020-00595
• 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
• Report Date: 04/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30335355M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1