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

Model Number D134801

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

Patient Problems Arrhythmia (1721); No Code Available (3191)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the complaint device for evaluation.The product 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.(b)(4).(b)(6).Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered complete atrioventricular (av) heart block requiring pacemaker implantation.During the procedure, when flushed the smartablate tubing, the irrigation of the thermocool® smart touch® sf bi-directional navigation catheter (lot # 30392088m) was insufficient.The catheter was replaced, and the issue was resolved.This issue of insufficient irrigation is not mdr reportable since intermittent or low irrigation is highly detectable by the physician and the potential that it could cause or contribute to a death or serious deterioration in state of health, is remote.Procedure was continued with a new thermocool® smart touch® sf bi-directional navigation catheter (lot# 30384765m).After pvc ablation the patient became bradycardic, and complete av heart block was confirmed.Isoproterenol was administered, but the issue remained.Temporary pacemaker was implanted, and the issue resolved.The physician commented that the causal relationship between the adverse event and the bwi product is unknown.There¿s no indication that extended hospitalization was required.No bwi product malfunctions were reported.

Manufacturer Narrative

It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered complete atrioventricular (av) heart block requiring pacemaker implantation.After pvc ablation the patient became bradycardic, and complete av heart block was confirmed.Isoproterenol was administered, but the issue remained.Temporary pacemaker was implanted, and the issue resolved.The physician commented that the causal relationship between the adverse event and the bwi product is unknown.There¿s no indication that extended hospitalization was required.No bwi product malfunctions were reported.Device evaluation details: the device evaluation has been completed.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 30384765m number, and no internal action related to the complaint was found during the review.The catheter passed all specifications.The root cause of the adverse event remains unknown.H6: component code of ¿g07002¿ (appropriate term/code not available) represents no device problem found (c19).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 1/24/2021, additional information was received indicating the patient was a 78-year-old female and the patient¿s condition had improved.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 10759796
• MDR Text Key: 213866123
• Report Number: 2029046-2020-01597
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30384765M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Date Manufacturer Received: 01/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO3 EXTERNAL REFPATCH 6PACK; PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE IRR TUBE SET; THMCL SMTCH SF BID, TC, D-D; CARTO3 EXTERNAL REFPATCH 6PACK; PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE IRR TUBE SET; THMCL SMTCH SF BID, TC, D-D
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR