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 Problems Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226)

Event Date 09/22/2021

Event Type  Injury  

Manufacturer Narrative

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 30559991m 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 a male patient underwent an atrial fibrillation (afib) with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade.At the time of hemostasis, mri was performed because blood pressure was low.It was found to have bleeding around the abdomen, and compression hemostasis was conducted again.After that, the patient started to have stable vitals, so the patient left the hospital.Cardiac tamponade.The physician commented that the event was not related to the product.Septal puncture was considered to be the cause.Additional information was received on the event.This adverse event was discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event was procedure related.Mri revealed bleeding from the abdomen.Mri and direct pressure hemostasis were performed.Patient outcome of the adverse event was improved.Prior to noting the cardiac tamponade, ablation was performed.No evidence of steam pop.No error messages observed on biosense webster equipment during the procedure.This event will conservatively assessed as mdr reportable as at the time, the hemostasis was post procedure and appears that ablation was performed.Therefore, the ablation catheter can not be ruled out as a cause.Should more information become available, it will be reviewed and processed accordingly.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) initially the event was assessed as a cardiac tamponade.However, during an internal review on (b)(6) 2021 a correction was noted to the assessment as the mri reports bleeding from the abdomen and therefore, should have been assessed as severe bleeding.Hence, processed h6.Health effect - clinical code to hemorrhage/bleeding (e0506).

• 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: 12637883
• MDR Text Key: 276585433
• Report Number: 2029046-2021-01762
• 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: 11/03/2021

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: 05/12/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30559991M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 11/01/2021
• Supplement Dates FDA Received: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention