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 No Code Available (3191)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Initial reporter phone: (b)(6).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 catheter and suffered atrioventircular (av) heart block requiring extended hospitalization.During ablation of cavotricuspid isthmus (cti), an av heart block occurred.The patient¿s vital signs were stable due to an escape beat.There¿s no indication that medical/surgical intervention was provided.Extended hospitalization was required for observation purposes.The physician commented that there was no causal relationship with this product.No biosense webster product malfunctions were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on august 3, 2020.The device evaluation was completed on august 12, 2020: it was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.During ablation of cavotricuspid isthmus (cti), an av heart block occurred.The patient¿s vital signs were stable due to an escape beat.There¿s no indication that medical/surgical intervention was provided.Extended hospitalization was required for observation purposes.The device was visually inspected, and it was found in good normal conditions.The magnetic, temperature and force features were tested, and no issues were observed.In addition, the catheter was deflected and irrigated correctly.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).

Manufacturer Narrative

Additional information was received on august 31, 2020.The patient is an 82 year old male.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: 10320616
• MDR Text Key: 200284374
• Report Number: 2029046-2020-00940
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30342292M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 82 YR