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

Model Number D134804

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

Patient Problem No Code Available (3191)

Event Date 08/19/2020

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 30376926m number, and no internal action related to the complaint was found during the review.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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

It was reported that a patient underwent ischemic ventricular tachycardia (isvt) ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered retroperitoneal hemorrhage requiring extended hospitalization but no intervention.It was reported by the caller the physician was having difficulty getting access while using a pre-closure device (perclose, abbott).The access was aborted and another attempt to gain access was obtained successfully.The caller states after access the catheter went in via venous access and they were able to map the right atrium with the ablation catheter.The caller then states the penatray catheter was used via retrograde access and they were able to gain access into the left ventricle.The caller states the patient became hypotensive and the patient's arterial blood pressure showed a significant drop.The caller states they ran a second hemoglobin test and it was 11.0.The baseline hemoglobin was 14.6.Due to the results of the second hemoglobin, the procedure was aborted.The caller states all the catheters were removed from the patient.The caller states the physician felt the perclose closure device was the reason for the retroperitoneal bleed.The caller states the physician does not believe any of the biosense webster catheters were at fault.The caller stated the patient was stable and manual pressure was being held on the access site.The caller stated that the patient was maintaining a good arterial pressure and was stable.No intervention was required, and the patient had fully recovered.Patient remained as inpatient for 2 days then procedure repeated.No bwi sheath was used in this procedure.With the information available, it has been determined that the involvement of biosense webster device cannot be excluded.Since the patient required extended hospitalization this event is considered serious injury.

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10551800
• MDR Text Key: 207568226
• Report Number: 2029046-2020-01292
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/19/2020

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: 06/21/2021
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30376926M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2020
• 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: ABBOTT PERCLOSE PRE-CLOSURE DEVICE; UNK_PENTARAY
• Patient Outcome(s): Other; Required Intervention