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

Model Number D134701

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pseudoaneurysm (2605)

Event Date 01/11/2022

Event Type  Injury  

Manufacturer Narrative

Additional 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.Investigation is in progress, once completed a supplemental will be submitted.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

During a clinical trial, it was reported that a (b)(6) male patient underwent an atrial fibrillation (afib) on (b)(6) 2022 with a thermocool® smart touch® sf uni-directional navigation catheter and suffered a vascular pseudoaneurysm which required surgical intervention and prolonged hospitalization.Postinterventional vigorously perfused pseudoaneurysm.The event start date was (b)(6) 2022.The patient required inpatient hospitalization and was admitted on (b)(6) 2022 and discharged on (b)(6) 2022.The adverse event was considered serious, but the severity was mild.The patient did not expire, and the event was not life threatening.An unknown medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function was required.There was serious deterioration in the health of the patient.The outcome is recovered/resolved.Per the study investigator the relationship to the device is considered not related.The relationship to the study procedure is probable.

Manufacturer Narrative

The investigation was completed on 25-mar-2022.Additional 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.A manufacturing record evaluation was performed for the finished device number 30648254l 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).

Manufacturer Narrative

Additional information was received on 05-apr-2022.Severity was moderate.The event was related to the index procedure and was expected/ anticipated.Additional information was received on 13-apr-2022.Regarding this event, a supplemental 3500a report will be subthe site awareness date has been updated from 28-feb-2022 to 14-feb-2022.If additional information is received mitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on 16-may-2022, removing the reported ¿non bwi sheath¿ as a concomitant product.Initially it was reported, ¿the relationship to the study procedure is probable.¿ additional information was received on 17-may-2022 updating the relationship to the study procedure as causal.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

Initially it was reported, ¿the event start date was 11-jan-2022.The patient required inpatient hospitalization and was admitted on (b)(6) 2022 and discharged on (b)(6) 2022.¿ additional information was received on 14-oct-2022 updating this information to the following: the event start date was 7-jan-2022.The patient required inpatient hospitalization and was admitted on (b)(6) 2022 and discharged on (b)(6) 2022.In addition, initially reported "unk_lasso" as a concomitant product.Additional information provided the lasso product information.Therefore, processed the "d10.Concomitant medical products and therapy dates" 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

Initially in the 3500a follow-up #4 it was reported that the patient was admitted on (b)(6) 2022.Additional information was received on 12-dec-2022 stating the admission date was updated to 11-jan-2022.However, additional information was received on 19-dec-2022, stating the admission date was updated to (b)(6) 2022.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 was received on 07-mar-2023 removing the coding of surgical intervention.Therefore, h6.Health effect - impact code of ¿surgical intervention (f19)¿ was removed.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 UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13897505
• MDR Text Key: 288115351
• Report Number: 2029046-2022-00626
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2022
• Device Model Number: D134701
• Device Catalogue Number: D134701
• Device Lot Number: 30648254L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7FR,DEF,15MM DIA., CCW,LASSO; NGEN RF GENERATOR; NON BWI SHEATH; UNK_CARTO 3; UNK_LASSO
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male