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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Heart Block (4444)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 cardiac ablation procedure for atrial fibrillation (afib) with thermocool® smart touch® sf bi-directional navigation catheter and suffered heart block.Intervention was not reported.After 5 hours since the procedure was started, during ablation atrioventricular conduction failure was noted.There was no problems with biosense webster products.After that, the procedure was completed without additional ablation.The patient left the room with atrioventricular block-like symptoms.Medication was administered and the patient is under observation.As of (b)(6) 2020 the atrioventricular block has not recovered.Based on the provided information the patient most probably suffered a complete heart block and required extended hospitalization.Since this 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.

Manufacturer Narrative

On (b)(6)2021, bwi received additional information regarding the reported event.The patient is a 37-year-old male.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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: 11000300
• MDR Text Key: 221276992
• Report Number: 2029046-2020-01936
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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
• Report Date: 11/19/2020

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 Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/13/2020
• Supplement Dates Manufacturer Received: 01/31/2021
• Supplement Dates FDA Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0055-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 37 YR