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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Air Embolism (1697); Transient Ischemic Attack (2109); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 an atrial fibrillation (afib) ablation procedure with a thermocool(r) smart touch(r) sf bi-directional navigation catheter and suffered air embolism.There was no error message no bwi product malfunction during the case.After transseptal puncture (bb), a drop in the patient's blood pressure was noted when the pentaray and livero catheters were placed.A soundstar catheter was used to check for an effusion which was not observed; however, since st segment elevation was noted, a coronary angiogram (cag) was done and the right coronary artery was found to be clogged; the echocardiography showed bubbles.Ischemic doctor was immediately called; the doctor instructed to remove the catheter from the patient's body.When the catheter (other than soundstar) was removed from the body, the bubble resolved.The physician commented that the microbubbles probably occurred from the rf needle.The patient was followed up.The doctor said that in magnetic resonance imaging (mri), microbubbles were seen in the area of the brain that controls language, and that language disorder may occur in the future.There's no report of interventions or prolonged hospitalization.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.For air embolism cases, the irrigation pump and sheath used are the first options to report under; however, with the information available and given the bubble issue was resolved upon catheter removal (other that soundstar catheter) this adverse event is conservatively assessed as mdr reportable under the ablation catheter (thermocool(r) smart touch(r) sf bi-directional navigation catheter).

Manufacturer Narrative

Additional information was received on 2/19/2021.The physician confirmed by echo that there were bubbles in the right coronary artery.Since there was a suspicion of air contamination by coronary angiography, air contamination was confirmed by echo.After further review of the information provided on 2/19/2021, it was assessed to add the patient consequence of ¿electrocardiogram st segment elevation¿.H6.Medical device problem code e2402 (appropriate term / code not available) used to represent "electrocardiogram st segment elevation" additional information was received on 3/1/2021.Immediately after the case, the patient had a language disorder; however, the bubble disappeared within 24 hours, and the next day the language disorder disappeared, and the patient was in good condition.After review of the additional information received on 3/1/2021 stating that the event resolved within 24 hours, it was assessed on 3/2/2021 to add ¿transient ischemic attack¿ as a patient consequence.Therefore, added under h6.Health effect - clinical code transient ischemic attack.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 (b)(6) 2021 a corrections were noted to the 3500a initial.H3.Device evaluated by manufacturer? was processed as ¿no¿.It should have been processed as ¿not returned to manufacturer¿.H3.Reason for non- evaluation was processed as ¿device evaluation anticipated, but not yet begun¿ and should have been left blank.H6.Type of investigation was processed as ¿type of investigation not yet determined¿ and should have been processed as ¿device discarded¿.In addition, under h10.Additional manufacturer narrative it should have included, ¿the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.¿.

Manufacturer Narrative

Additional information was received on (b)(6)/2021.The patient was a 64-year-old male patient (60 kg).Therefore, a 2.Patient age at the time of event, a 2.Age unit, a 3.Gender, a 4.Weight of the patient, and a 4.Weight unit.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 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 30448183m 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).

• 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: 11346465
• MDR Text Key: 232840685
• Report Number: 2029046-2021-00205
• 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: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30448183M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 02/18/2021; 02/19/2021; 04/15/2021; 04/15/2021
• Supplement Dates FDA Received: 02/19/2021; 03/08/2021; 04/15/2021; 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON BWI-LIVERO CATHETER; PENTARAY NAV ECO 7FR, D, 2-6-2; SOUNDSTAR ECO GE 8F CATHETER; UNKNOWN BRAND RF NEEDLE
• Patient Outcome(s): Life Threatening
• Patient Age: 67 YR
• Patient Weight: 60