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 Vasoconstriction (2126)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30527178ma number, and no internal action related to the complaint was found during the review.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 an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered st elevated, coronary artery spasm requiring angiograph and nitro was administered by drip infusion and then via coronary injection.After the procedure, when the physician noticed that st was elevated during hemostasis, the patient was determined to have spasms, and then nitro was administered by drip infusion, but it did not help it.Nitro was directly administered by coronary artery injection.St depression was immediately observed, and angiography also confirmed that blood vessels had expanded, and the patient was also stable.Angiography also confirmed that blood vessels had expanded, and the patient was also stable.Regarding the clinical course, the physician said there was no problem since st elevation was not observed thereafter.The physician commented that patient origin, not product origin.It is life threatening; it might result in permanent impairment of a body function or permanent damage to a body structure; or it required medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

Manufacturer Narrative

On (b)(6)2021, bwi received additional information regarding the event.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event: patient condition.The event did not require medical or surgical intervention: directly flush the nitro with coronary injection.Patient outcome of the adverse event: 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).

• 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: 12197133
• MDR Text Key: 262469506
• Report Number: 2029046-2021-01156
• 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: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30527178MA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PENTARAY NAV; SOUNDSTAR ECO; PENTARAY NAV; SOUNDSTAR ECO
• Patient Outcome(s): Life Threatening; Required Intervention