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

Catalog Number D134701

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

Patient Problem Respiratory Tract Infection (2420)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.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.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device 30133158l number, and no internal action was found during the review.Concomitant medical products: visitag surpoint epu (us catalog # d160801, lot #30103136l).Manufacturer¿s ref # (b)(4).

Event Description

During a clinical trial, sponsored by biosense webster inc.(bwi), it was reported that a (b)(6) female patient underwent a pulmonary vein isolation (pvi) ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch® sf uni-directional navigation catheter and developed aspiration pneumonia requiring medication.On post-procedure day 1, the patient developed aspiration pneumonia in the lung left lobe.An unspecified medication was administered.Extended hospitalization was required as a result of the event.The principal investigator assessed this event as mild in severity, serious, unrelated to the study device (visitag surpoint), unrelated to the study catheters, unrelated to the bwi no-investigational devices and causal relationship to the index procedure.

Manufacturer Narrative

On 5/23/2019, bionsense webster inc.Received additional information indicating the principle investigator updated the adverse event term of "aspiration pneumonia a in the lung left lobe" to "aspiration" and logged "left lobe infiltrate" as a separate adverse event.Correction: on 6/17/2019, it was identified that incorrect information was reported in the initial mdr.It was reported that no product had been returned at the time of submitting the initial 3500a.However, it should have been reported that the product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.As such, the method code has been corrected from 4114 (device not returned) to 4115 (device discarded).Additionally, on 6/17/2019, it was noticed that the following concomitant products were inadvertently omitted from the initial mdr: concomitant bwi products - smartablate rf generator (us catalog # m490007, serial # (b)(4)); thermocool smarttouchsf/st interface cable (us catalog # cr3434ct, lot # unknown); carto 3 v6.0 system (us catalog # unknown, serial # lot); carto external reference patches (us catalog # crefp6, lot # unknown); smartablate irrigation pump (us catalog # unknown, serial # lot).Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

On 7/16/2019, additional information was received indicating the severity of the event has been assessed as moderate.It was previously assessed as mild.Manufacturer¿s ref # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 8609920
• MDR Text Key: 145087136
• Report Number: 2029046-2019-03144
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• 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,study
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Catalogue Number: D134701
• Device Lot Number: 30133158L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 100