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

Catalog Number D134805

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

Patient Problem Blood Loss (2597)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.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 (b)(6) male patient underwent a supraventricular tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered bleeding.During the procedure, when clicking on one of the points on the sur point graph, the carto 3 system application crashed.The workstation was rebooted, and the procedure was continued.Post procedure, once all the catheters were removed, and the patient was being extubated, there was about 200 cc of blood removed from the patients mouth and esophagus.Patient was stable and no further intervention is planned.Extended hospitalization was not required.The patient has fully recovered.Physician¿s opinion on the cause of the event is that it was patient condition related from a pre-existing gastric issue and difficult intubation/extubating.Patient had history of gastrointestinal (gi) bleeding and was scheduled to have upper and lower gi study prior to the procedure.

Manufacturer Narrative

It was reported that a 60-year-old male patient underwent a supraventricular tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered bleeding.During the procedure, when clicking on one of the points on the sur point graph, the carto 3 system application crashed the biosense webster inc.Product analysis lab received the device for evaluation.The investigational analysis completed on (b)(6)2020.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 and no internal actions were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.Physician¿s opinion on the cause of the event is that it was patient condition related from a preexisting gastric issue and difficult intubation/extubating.Manufacture reference no: (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: 9500070
• MDR Text Key: 188138523
• Report Number: 2029046-2019-04038
• 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: 11/20/2019

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: 08/12/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30269752M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention