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

Model Number D134805

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

Patient Problem Paralysis (1997)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report 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

It was reported that a patient with history of lung resection underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered diaphragmatic paralysis.During the procedure while ablating the superior vena cava (svc), the physician carefully ablated where the diaphragm was captured.Physician immediately stopped the ablation when noticed the diaphragm was no longer captured by pacing.Phrenic nerve damage occurred.The patient did not show subjective symptoms.There¿s no indication that medical/surgical intervention or extended hospitalization was required.Patient¿s condition improved.The physician commented that it is possible that a previous lung resection operation was the cause of the issue.No bwi product malfunctions were experienced throughout the procedure.The contact force (cf) was between 2-12 grams with an average of 6 grams.The ablation was performed at 25 watts for 6 seconds.Since this event might result in permanent impairment of a body function or permanent damage of a body structure, then it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 11/9/2020, the product investigation was completed.It was reported that a patient with history of lung resection underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered diaphragmatic paralysis.During the procedure while ablating the superior vena cava (svc), the physician carefully ablated where the diaphragm was captured.Physician immediately stopped the ablation when noticed the diaphragm was no longer captured by pacing.Phrenic nerve damage occurred.The patient did not show subjective symptoms.There¿s no indication that medical/surgical intervention or extended hospitalization was required.Patient¿s condition improved.The physician commented that it is possible that a previous lung resection operation was the cause of the issue.Device evaluation details: the device was visually inspected and it was found in good conditions.The magnetic, temperature and force features were tested and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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: 10681214
• MDR Text Key: 212097060
• Report Number: 2029046-2020-01473
• 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: 09/16/2020

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: 07/08/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30394376M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 11/09/2020
• Supplement Dates FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; PENTARAY NAV; SOUNDSTAR ECO SMS 8F CATHETER
• Patient Outcome(s): Life Threatening