MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D128211

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2020

Event Type  malfunction  

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 30391101l number, and no internal action related to the complaint was found during the review.(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).Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's reference number: (b)(4).

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.In addition, thrombus was observed on both the pentaray nav high-density mapping eco catheter and the thermocool® smart touch® sf bi-directional navigation catheter.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.Since cerebrovascular accident event may be life threatening; might result in permanent impairment of a body function or permanent damage to a body structure; or required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it is mdr reportable.This adverse event was assessed mdr reportable under the thermocool® smart touch® sf bi-directional navigation catheter.The thrombus was assessed as an mdr reportable malfunction under both the thermocool® smart touch® sf bi-directional navigation catheter and the pentaray nav high-density mapping eco catheter.

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 a3.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 it was reported that the thrombus issue was assessed as a mdr reportable malfunction under both the thermocool® smart touch® sf bi-directional navigation catheter and the pentaray nav high-density mapping eco catheter.However, during review on 5/20/2021, a correction was noted to the assessment under the thermocool® smart touch® sf bi-directional navigation catheter.The 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.

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10505908
• MDR Text Key: 207325216
• Report Number: 2029046-2020-01194
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• PMA/PMN Number: K123837
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2023
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30391101L
• 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: THMCL SMTCH SF BID, TC, D-F