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

Model Number D132705

Device Problems Insufficient Cooling (1130); High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Pericardial Effusion (3271)

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 (b)(4) number, and no internal actions 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 patient underwent an ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter.The patient suffered chest pain, and pericardial effusion was observed.The patient was hospitalized for observation.After the procedure, although the patient was discharged from the hospital without any problem, the patient visited the emergency department complaining of chest pain, and pericardial effusion was observed.The patient was hospitalized and under follow-up observation.No drainage was performed.The physician commented that recognition of the event that occurred when the contact force increased when the inside of the coronary sinus was ablated with the thermocool® smart touch¿ bi-directional navigation catheter and at the same time the contact force was caught by the temperature limiter and the ablation stopped, or the event that occurred when the webster 4 pole ¿d4s04fr005rt¿ catheter was used as an hra catheter and was poorly fixed and placed in the right atrial appendage.The pericardial effusion adverse event was assessed as mdr reportable as it required prolonged hospitalization.This adverse event was assessed as mdr reportable under the under thermocool® smart touch¿ bi-directional navigation catheter.The high temperature was assessed as not mdr reportable.Since the user-defined cut-off was not exceeded the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, was remote.The high force issue was assessed as not mdr reportable.The issue was highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event was low.

Manufacturer Narrative

In the 3500a follow-up #1 report, we reported that initially the reported device was a thermocool® smart touch¿ bi-directional navigation catheter lot # 30514945m; however, in the additional information received, they responded that a thermocool® smarttouch® sf catheter was used.Therefore, we requested clarification on which device was used.On (b)(6) 2021 additional clarification was received stating that the correct product used was the thermocool® smart touch¿ bi-directional navigation catheter.Therefore, the correct reportable device was reported in the 3500a initial.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information received on 10-aug-2021.The patient was a 50 year old male.This adverse event was discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that it was procedure related.No intervention was provided.The patient was discharged once but he was hospitalized again due to the effusion.Patient¿s weight is 70kg.A thermocool® smarttouch® sf catheter was used.There was no evidence of steam pop.Therefore, section a.Patient information has been processed accordingly.Initially the reported device was a thermocool® smart touch¿ bi-directional navigation catheter lot # 30514945m; however, in the additional information received, they responded that a thermocool® smarttouch® sf catheter was used.Therefore, requesting clarification on which device was used.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 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: 12038258
• MDR Text Key: 257400860
• Report Number: 2029046-2021-00964
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2022
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30514945M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEF 4F,4P,F,SD,5MM,10PN,110CM; UNKNOWN BRAND HRA CATHETER; DEF 4F,4P,F,SD,5MM,10PN,110CM; UNKNOWN BRAND HRA CATHETER
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR
• Patient Weight: 70