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

Model Number D134805

Device Problems High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Hematoma (1884)

Event Date 12/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.At the time of cavotricuspid isthmus (cti) ablation, the patient¿s blood pressure decreased while operating the catheter on the inferior vena cava (ivc) side.Pericardial fluid was confirmed to be accumulating.Pericardiocentesis was performed to drain the fluid; however, patient¿s vital signs did not return to normal and the bleeding did not stop resulting in hematoma.Reminder of the procedure was aborted.Unspecified medication was administered and a transient increase in blood pressure was achieved, but the bleeding did not stop.The pericardial fluid hematoma progressed, and dilatation failure occurred.The patient¿s blood pressure decreased again as well as oxygen saturation (sp02).The patient was sent to surgery for hematoma removal.Surgical intervention was successful, and hemostasis was achieved.The patient was reported to be in stable condition.It is unknown if prolonged hospitalization was required.Physician stated that the perforation might have occurred when the ablation catheter entered the agilis sheath and was taken out, which resulted in high contact.No bwi product malfunctions were reported.The physician also stated when using lao view (unclear), there was a location pad and it could not see, so it lacked safety.Further follow up is to be conducted to obtain clarification to this information as it is not clear if during the case, an issue with the location pad occurred.Since the event is life threatening and required surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, then it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On (b)(6) 2021, bwi received additional information regarding the event.The patient is a 73-year-old female patient (42kg).It is most likely that prolonged hospitalization was required to recover from surgery.There was no evidence of steam pop during the ablation.On (b)(6) 2021, bwi also received further clarification of the following: during the procedure, when seeing from lao view, the location pad hid the agilis sheath and it was difficult to definitively identify the location of agilis sheath, possibly resulting in less safety from the operating physician.Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30441660m number, and no internal action elated 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).

• 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: 11175768
• MDR Text Key: 227004404
• Report Number: 2029046-2021-00062
• 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: 12/23/2020

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: 09/23/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30441660M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 01/24/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO3 EXTERNAL REFPATCH 6PACK.; DECANAV.; DECANAV.; JPN CARTO 3 SYSTEM.; PENTARAY NAV ECO 7FR, D, 2-6-2.; SMARTABLATE IRR TUBE SET.; CARTO3 EXTERNAL REFPATCH 6PACK; DECANAV; DECANAV; JPN CARTO 3 SYSTEM; PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE IRR TUBE SET
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 42