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

Model Number D134801

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

Patient Problem Nerve Damage (1979)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Initial reporter phone: (b)(6).(b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered phrenic nerve injury.Phrenic nerve palsy was observed (the right diaphragm was paralyzed).The physician commented that isolation could not be achieved and many ablations were performed to right pulmonary veins (rpvs).There was no report of product malfunction.No information about intervention, prolonged hospitalization was provided.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available in the future; the reportability decision will be reassessed.

Manufacturer Narrative

Per internal review on (b)(6)2020 , multiple corrections to the initial report were identified.The corrections are detailed below: it was discovered that the "life threatening" selection in section b2 in the initial report was inaccurate.Internal review has determined that the event was not life threatening and the "other serious" selection has been checkmarked in its place.Additionally, the complaint device is expected to return.Therefore, the h6 method/result/conclusion codes have been updated accordingly.Thirdly, it was erroneously indicated within h10 of the initial report that a manufacturing record evaluation (mre) cannot be conducted because the customer did not provide a lot number.However, a lot number was provided by the customer and documented within the initial report.Correction: a manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Furthermore, if any additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number:pc-000723559.

Manufacturer Narrative

Additional information was received on 7/21/2020.The patient is a 67 years-old female patient (68kg).The physician¿s opinion is that the event was procedure related.No medical intervention was required.The patient¿s condition has improved.Therefore, updated a 2.Patient age at the time of event, a 2.Age unit, a 4.Weight of the patient, a 4.Weight unit and a3.Sex.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-000723559.

Manufacturer Narrative

Additional information received on august 25, 2020 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 30269717m 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).

• 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: 10292737
• MDR Text Key: 199533011
• Report Number: 2029046-2020-00896
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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,Followup,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2020
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30269717M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 67 YR
• Patient Weight: 68