MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D131502
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® sf nav uni-directional catheter.Initially, it was reported that there was noise on all electrocardiograms when the thermocool® sf nav uni-directional catheter was connected to the patient interface unit.The issue was resolved by replacing the catheter.No patient consequence has been reported.Since there was no evidence there were no interpretable signals on all body surface and intracardiac signals on all systems, this event was assessed as not reportable.The risk to the patient was low.Additional information was received on (b)(6) 2018.It was clarified that no signals were available until the catheter was changed.The issue was observed on all intracardiac and body surface signals on the carto system and recording system.In addition, no signals were available on the defibrillator and anesthesia monitor.Per the additional information describing that no signals were available on any system until the catheter was changed, this event was re-assessed to not reportable.The awareness date is (b)(4) 2018.
Additional Manufacturer Narrative
During an internal review, it was noted that there is a correction to the initial report.In the initial it stated,¿per the additional information describing that no signals were available on any system until the catheter was changed, this event was re-assessed to not reportable.¿ it should have stated, ¿per the additional information describing that no signals were available on any system until the catheter was changed, this event was re-assessed to reportable.¿ manufacturer's ref no: (b)(4).
Additional Manufacturer Narrative
The biosense webster inc.Product analysis lab received the device for evaluation on (b)(6) 2018.Therefore, populated concomitant medical products.Device available for evaluation?, concomitant medical products.Is device returned to manufacturer? and concomitant medical products.Date device returned to manufacturer.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
Correction to 3500a initial report field ¿date received by manufacturer¿.The awareness date was 11/12/2018 as stated in the 3500a initial report in the event description.Therefore, the ¿date received by manufacturer¿ field should have reflected from 10/26/2018 to 11/12/2018.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The device history record has been provided on (b)(6)2018.The device history record (dhr) for the lot number 30075419l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.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.Manufacturer's ref.No:(b)(4).
Additional Manufacturer Narrative
Investigation summary: it was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® sf nav uni-directional catheter.Initially, it was reported that there was noise on all electrocardiograms when the thermocool® sf nav uni-directional catheter was connected to the patient interface unit.The issue was resolved by replacing the catheter.No patient consequence has been reported.Additional information was received.It was clarified that no signals were available until the catheter was changed.The issue was observed on all intracardiac and body surface signals on the carto system and recording system.In addition, no signals were available on the defibrillator and anesthesia monitor.The device was visually inspected and it was found in good conditions.Then, electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint cannot be confirmed.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8096771
• Report Number: 2029046-2018-02324
• Device Sequence Number: 14139663
• Product Code: LPB
• UDI-Device Identifier: 10846835009248
• UDI-Public: 10846835009248
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2021
• Device Catalogue Number: D131502
• Device Lot Number: 30075419L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 11/21/2018; 11/28/2018; 12/07/2018; 12/17/2018; 01/14/2019
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 11/21/2018; 11/29/2018; 12/07/2018; 12/27/2018; 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1