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); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 08/11/2020

Event Type  Injury  

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 lot# 30380126m, and no internal actions 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.Initial reporter phone: (b)(6).Manufacturer's reference number: (b)(4).Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc, or its employees that the report constitutes an admission that the product, biosense webster inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a patient underwent atrial fibrillation (afib) ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered cerebrovascular accident requiring hospitalization.It was reported that pulmonary vein isolation (pvi) and atrial tachycardia (mitral at) ablation were performed.Because of at from the time of entry, pvi was performed, and then at was mapped by pentaray nav high-density mapping eco catheter.The patient was diagnosed with mitral at.When induced after cavotricuspid isthmus (cti) ablation another at appeared.Mapping with pentaray nav high-density mapping eco catheter again led to a diagnosis of mitral at.In the end of the procedure thrombus was confirmed at the tip of thermocool® smart touch® sf bi-directional navigation catheter and pentaray nav high-density mapping eco catheter at the end of the procedure.Saline flowed without any problem.After completion of the case, the patient returned to the ward, but as the patient was waking up late, mri was performed and cerebral infarction was found.The patient did not return to consciousness.The physician¿s commented that possible cause of prolonged case time (size of left atrium, multiple treatments given).Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available in the future; the reportability decision will be reassessed.

Manufacturer Narrative

During an internal review on (b)(6)2020 , corrections were noted to the 3500a initial."h6.Device codes" was processed as ¿adverse event without identified device or use problem¿ and should have been processed as ¿coagulation in device or device ingredient¿.In error ¿b1.Is product problem¿ was not checked.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 on the event was received on 10/8/2020.The patient¿s gender is male.The event was discovered post use of biosense webster products (ventricular tachycardia - during use, cerebral infarction -post use).The physician¿s causality opinion is procedure.The intervention was drug treatment aimed at thrombolysis.The patient¿s condition is unchanged.Therefore, populated a 3.Sex field.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) initially this event was also assessed as mdr reportable for a thrombus malfunction issue under the thermocool® smart touch® sf bi-directional navigation catheter.During review on 5/20/2021, a correction was noted to the assessment as this thrombus issue under the thermocool® smart touch® sf bi-directional navigation catheter 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: 10491032
• MDR Text Key: 205728241
• Report Number: 2029046-2020-01162
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30380126M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PENTARAY NAV ECO 7FR, D, 2-6-2.
• Patient Outcome(s): Life Threatening