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

Model Number D134805

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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.(b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a clot issue occurred.After 2 hours since the ablation started, the catheter was checked and a blood clot was noted.The catheter was changed.The procedure was completed without any patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available the clot issue noted on the catheter was assessed as a reportable malfunction.

Manufacturer Narrative

Correction noted on 12/17/2019 to the 3500a initial report as the concomitant products were not included in the ¿concomitant medical products and therapy dates¿ field.Therefore, submitting a correction follow-up report to include this information.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

Additional information was received on(b)(6)2019.There were no error messages about the catheter when the clot occurred.The smartablate generator was used in this procedure.Therefore, processed the ¿¿d11.Concomitant medical products and therapy dates¿ field.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The product investigation was completed on (b)(6)2020.Investigation summary: it was reported that a patient underwent a procedure with a thermocool® smart touch® sf bi-directional navigation catheter.After 2 hours since the ablation started, the catheter was checked and a blood clot was noted.There were no error messages about the catheter when the clot occurred.The catheter was changed.The procedure was completed without any patient consequence.The device was visually inspected and it was found in good conditions.Then, electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Also, an irrigation test was performed and the catheter was found irrigating correctly.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed since the device was found working correctly and no evidence of clot residue was observed on the catheter; however, the root cause of the clot reported by the customer could be related to the usage of the device during the procedure.However this cannot be conclusively determined.Manufacturer¿s reference number:(b)(4).

Manufacturer Narrative

A correction was noted to follow-up #2 as it was stated that the "smartablate generator was used in this procedure.Therefore, processed the ¿¿d11.Concomitant medical products and therapy dates¿ field".In error, this field was not populated.Therefore, it has been processed.Manufacturer's reference number: pc-(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: 9484587
• MDR Text Key: 199722797
• Report Number: 2029046-2019-04015
• 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
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30233274M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 12/17/2019; 01/22/2020; 01/22/2020
• Supplement Dates FDA Received: 12/19/2019; 01/23/2020; 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LASSO NAV 2515,22P SPLITHANDLE; THMCL SMTCH SF BID, TC, D-F; UNK_SMARTABLATE GENERATOR