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

Model Number D134801

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

Patient Problems Bradycardia (1751); No Code Available (3191)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.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

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheters were used, and developed bradycardia requiring medication and surgical intervention (pacemaker implantation).When superior vena cava (svc) isolation was conducted, right after pulmonary vein isolation was completed, the patient developed bradycardia.The patient¿s heart rhythm dropped to about 20 beats per minute (bpm).An unspecified medication was administered; however, the rate did not rise.A temporary pacemaker was implanted.Patient¿s condition was checked the day after, and it was confirmed the heart rhythm restored to sinus.It is unknown if extended hospitalization was required as result of the adverse event.The physician commented the issue was not caused by the biosense webster (bwi) product.No biosense webster, inc.Product deficiencies were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

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 30384669m number, 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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on 12/10/2020 stating that the patient¿s gender is male.Therefore, a3.Gender field was processed.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 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: 10618398
• MDR Text Key: 209565611
• Report Number: 2029046-2020-01380
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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
• Report Date: 09/02/2020

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: 06/15/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30384669M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 12/10/2020; 01/08/2021
• Supplement Dates FDA Received: 01/07/2021; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PENTARAY NAV ECO 7FR, D, 2-6-2.; SOUNDSTAR ECO SMS 8F CATHETER.; PENTARAY NAV ECO 7FR, D, 2-6-2; SOUNDSTAR ECO SMS 8F CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention; Disability