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

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a female patient ((b)(6) year old) underwent cardiac ablation procedure for atrioventricular nodal reentrant tachycardia (avnrt) with thermocool® smart touch® sf bi-directional navigation catheter and suffered atrioventricular (av) heart block requiring pacemaker implantation.It was reported that while the ablation was on for approximately 14 seconds junctional rhythm was noticed and the ablation was turned off.The atrium and ventricle became dissociated.The physician placed a temporary pacemaker in the patient and will send the patient for observation overnight.If normal rhythm is not restored a permanent pacemaker will be scheduled.Patient stable at the time of the call.The event occurred during use of biosense webster products.The physician's opinion is that the cause of the event was procedure.Everything was working fine and he ablated for 13.92 seconds, according to the visitag information.He also said that the patient may have had a rare anatomy where the av node was more anterior than normal.Surgical intervention was not required.The patient's condition required extended hospitalization.The patient stayed at the hospital overnight with a temporary pacemaker to see if their av conduction would recover.The final outcome is unknown.Since this event required medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it is mdr reportable.

Manufacturer Narrative

On 1/4/2021, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a female patient (74 year old) underwent cardiac ablation procedure for atrioventricular nodal reentrant tachycardia (avnrt) with thermocool® smart touch® sf bi-directional navigation catheter and suffered atrioventricular (av) heart block requiring pacemaker implantation.It was reported that while the ablation was on for approximately 14 seconds junctional rhythm was noticed and the ablation was turned off.The atrium and ventricle became dissociated.The physician placed a temporary pacemaker in the patient and will send the patient for observation overnight.If normal rhythm is not restored a permanent pacemaker will be scheduled.Patient stable at the time of the call.The event occurred during use of biosense webster products.The physician's opinion is that the cause of the event was procedure.Everything was working fine and he ablated for 13.92 seconds, according to the visitag information.He also said that the patient may have had a rare anatomy where the av node was more anterior than normal.Surgical intervention was not required.The patient's condition required extended hospitalization.The patient stayed at the hospital overnight with a temporary pacemaker to see if their av conduction would recover.The final outcome is unknown.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 for the finished device 30401859m number, and no internal action was found during the review.The catheter passed all specifications.The root cause of the adverse event remains unknown.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: 11000350
• MDR Text Key: 221237854
• Report Number: 2029046-2020-01937
• 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
• 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 Expiration Date: 07/29/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30401859M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR