MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL SMART TOUCH SF NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

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

Patient Problems Syncope (1610); Heart Failure (2206)

Event Date 03/27/2020

Event Type  Injury  

Manufacturer Narrative

Information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.(b)(6).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

During a clinical trial, non-bwi sponsored, it was reported that a patient underwent a cardiac ablation procedure for paroxysmal atrial fibrillation with a thermocool® smart touch® sf navigation catheter on (b)(6) 2020 and developed worsening congested heart failure and syncope (swoon).During the procedure, the ablation was performed with the thermocool® smart touch® sf navigation catheter.No device deficiency was reported.The procedure was successfully completed.Post-procedure ((b)(6) 2020), the patient developed worsening congestive heart failure.There¿s no information on if medical/surgical intervention or extended hospitalization was required.The principal investigator assessed the event as serious, not related to the study device and perhaps not related to the procedure.Since this event has implied relationship to the procedure and it is listed in the product instructions for use (ifu) as a potential side effect from the ablation procedure, it will be reported as an adverse event.In addition, the event occurred a few days after the procedure; therefore, the relationship between its occurrence and the ablation procedure cannot be excluded.Post-procedure ((b)(6) 2020), the patient developed syncope (swoon).There¿s no information on if medical/surgical intervention or extended hospitalization was required.The principal investigator assessed the event as serious, not related to the study device and perhaps not related to the procedure.Since this event has implied relationship to the procedure it will be coded as ¿syncope¿.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available, it will be reviewed and processed accordingly.

Manufacturer Narrative

On 9/22/2020, biosense webster inc.Received the name of the initial reporter's full name as (b)(6) hospital".As such, the respective fields in section e.Initial reporter have been populated.E1.Initial reporter phone: (b)(6).E1.Initial reporter fax: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 12/10/2020, biosense webster inc.Received additional information about the patient and event.It was reported the patient was a 72-year-old female patient (weighing 53.4 kg).Patient¿s condition had improved.The principal investigator has reassessed the event as serious, probably not related to the study device and perhaps not related to the procedure.Additional patient history was also provided and has been added to field b7.Medical history/preexisting condition.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On(b)(6)-2021, biosense webster inc.Received additional information about the patient and the event.It was reported the patient's height was 160.0 cm.Patient¿s medical history included hypertension (systolic blood pressure = 140 mmhg).It was indicated the patient required extended hospitalization due to the severity/degree of the adverse event.It was also clarified the patient had developed worsening congestive heart failure on (b)(6)-2020 and not on (b)(6)-2020.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 NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10544594
• MDR Text Key: 207907612
• Report Number: 2029046-2020-01282
• Device Sequence Number: 1
• Product Code: LPB
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 53