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

Model Number D134801

Device Problems Device Contamination with Body Fluid (2317); Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/24/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30467038m number, and no internal action related to the complaint was found during the review.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 tachycardia (at) with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a thrombus.During ablation, an intracardiac thrombus was found.Ablation was conducted for left atrium posterior wall and ultrasonography showed a thrombus attached to the posterior wall of the la.At that time, when the tip of the thermocool® smart touch® sf bi-directional navigation catheter was looked at, adhesion of the thrombus was confirmed, but it was resolved by wiping off.When the sheath tip was attached to the thrombus and sucked with a 20 ml syringe, the thrombus was recovered in the syringe.The procedure was successfully completed.The patient fully recovered.There is no further information about the hospitalization.The procedure was completed without patient's consequence.

Manufacturer Narrative

Additional information was received on (b)(6)2021 stating that the patient not exhibit any neurological symptoms since the procedure was completed.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

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 12-jul-2021, corrections were noted to the 3500a initial.¿h6.Health effect - impact code¿ was processed as ¿recognized device or procedural complication (f15)¿ and should have been processed as ¿surgical intervention (f19)¿.Per the event reported under the 3500a initial that the tip of the thermocool® smart touch® sf bi-directional navigation catheter was looked at and adhesion of the thrombus was confirmed, a correction was noted as the mdr reportable malfunction code under ¿h6.Medical device problem code¿ of ¿device contamination with body fluid (a180103)¿ should have been included.In addition ¿b1.Is product problem¿ should have been checked.

• 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: 11704211
• MDR Text Key: 248905434
• Report Number: 2029046-2021-00624
• 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,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30467038M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Life Threatening