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

Model Number D134805

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

Patient Problems Low Blood Pressure/ Hypotension (1914); No Code Available (3191)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.A manufacturing record evaluation was performed for the finished device 30258726m number, and no internal actions related to the complaint was found during the review.Manufacturer's reference # (b)(4).

Event Description

It was reported that a (b)(6)-year-old male patient underwent a persistent atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered low ejection fraction, low blood pressure and low oxygen levels requiring surgical intervention.When the catheter was re-zeroed, the force would go to 0 g, and every time the catheter was re-positioned, the carto 3 system displayed a force error 87 (force values may not be accurate).Re-zeroing was attempted several times without resolution.The cable was replaced without resolution.However, replacing the catheter resolved the issue.The carto 3 system is operating per specifications and is not responsible for the product issue.The procedure was continued.Extended hospitalization was required.The physician¿s opinion on the cause of this adverse event was not related to the ablation procedure but related to the patient condition.After the procedure was completed, it was discovered that the patient was not doing well hemodynamically.The patient's ejection fraction, blood pressure and oxygenation levels were very low.The medical intervention provided was an implantation of an abiomed impella heart pump to aid in blood flow from the heart to the aorta.The patient was reported to be in stable condition and improving.The patient was transferred to the intensive care unit (icu) for monitoring.The force sensor issue was assessed as not mdr reportable since the potential risk that they could cause or contribute to a death or serious injury is remote.

Manufacturer Narrative

On december 6, 2019, additional information was received, and it was noted that proper testing was performed and concluded that the tamponade was not the cause but related to the patient¿s pre-existing condition.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference # (b)(4).

Manufacturer Narrative

On january 21, 2020, the complaint details were re-reviewed, and it was determined that the challenges with the catheter were unrelated to the event.The physician reports the hemodynamic challenges are attributed to patient¿s condition.Cardiac tamponade was excluded.The hypotension reported against the thermocool® smart touch® sf bi-directional navigation catheter product is no longer considered to be an mdr reportable malfunction against the thermocool® smart touch® sf bi-directional navigation catheter.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference # (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: 9377392
• MDR Text Key: 180630247
• Report Number: 2029046-2019-03936
• 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,Followup
• Report Date: 11/11/2019

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: 07/22/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30258726M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 12/06/2019; 01/21/2020
• Supplement Dates FDA Received: 12/18/2019; 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABIOMED IMPELLA HEART PUMP; CARTO 3 SYSTEM
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 83