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

Model Number D134805

Device Problems Failure to Sense (1559); Patient Device Interaction Problem (4001)

Patient Problem Paralysis (1997)

Event Date 06/17/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with two thermocool® smart touch® sf bi-directional navigation catheter and suffered a diaphragmatic paralysis.When the smart touch catheter was connected error 105 (magnetic sensor error) displayed.The cable was changed but the issue continued.The catheter was changed, and the issue resolved.During ablation of the superior vena cava there was difficulty moving the diaphragm.The diaphragm gradually recovered on its own.The procedure completed without any action and the patient left from the room as usual.The diaphragmatic paralysis was considered non-serious, moderate/minimal.No further information is available at this time.The magnetic sensor error is not mdr-reportable.However, since this event is life threatening and required interventions to prevent permanent impairment of a body function or permanent damage to a body structure, then is to be considered serious and mdr-reportable.This report is for the 2nd of 2 thermocool® smart touch® sf bi-directional navigation catheters.The other catheter was reported in manufacturer report number 2029046-2021-01053.

Manufacturer Narrative

On (b)(6)2021, bwi received additional information regarding the event.This adverse event was discovered during use of biosense webster products.No intervention was provided.Patient outcome was reported as improved.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

On 21-sep-2021, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.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; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12124842
• MDR Text Key: 266300002
• Report Number: 2029046-2021-01054
• 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,Followup
• Report Date: 06/17/2021

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: 04/04/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30509644M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 07/07/2021; 09/21/2021
• Supplement Dates FDA Received: 07/26/2021; 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening