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

Model Number D134801

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter where blood clot occurred.After 4 hours since first ablation the physician felt discomfort with the imp value of thermocool® smart touch® sf bi-directional navigation catheter during ablation, and then pulled it out of the patient¿s body and confirmed the tip of thermocool® smart touch® sf bi-directional navigation catheter, had a thrombus had adhered.The issue was resolved by changing the catheter to another one.The procedure was completed without patient's consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information becomes available in the future; the reportability decision will be reassessed.

Manufacturer Narrative

It was reported that a patient underwent cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter where blood clot occurred.After 4 hours since first ablation the physician felt discomfort with the imp value of thermocool® smart touch® sf bi-directional navigation catheter during ablation, and then pulled it out of the patient¿s body and confirmed the tip of thermocool® smart touch® sf bi-directional navigation catheter, had a thrombus had adhered.The issue was resolved by changing the catheter to another one.The procedure was completed without patient's consequence.On (b)(6) 2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.The complaint catheter was inspected, and it was found in good normal condition.No thrombus/clot trail was detected.Device evaluation details: the device evaluation has been completed.Upon receipt, the catheter was visually inspected and it was found in normal conditions: no trails of thrombus were observed.Then, per the complaint, an irrigation test was performed and the catheter passed the test: no irrigation issues were detected.A manufacturing record evaluation was performed for the finished device number and no internal action related to the complaint was found during the review.The customer complaint cannot be duplicated as intended.The device was found working correctly and no evidence of thrombus residues were observed on the catheter.The device was found working in specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 10552348
• MDR Text Key: 207535189
• Report Number: 2029046-2020-01298
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30384670M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THMCL SMTCH SF BID, TC, D-D; THMCL SMTCH SF BID, TC, D-D