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

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Paralysis (1997)

Event Date 08/06/2021

Event Type  Injury  

Manufacturer Narrative

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 30532962m number, and no internal action 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 female patient underwent an atrial tachycardia (at) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered phrenic nerve paralysis.There was a tendency toward diaphragmatic neuropathy when at was mapped to ra.When cti ablation, suspected pop and phrenic nerve paralysis.Diaphragmatic nerve paralysis was confirmed during at ablation, and the patient left as it was recovering over time.The physician¿s opinion on the cause of this adverse event: during the ablation of ra, diaphragmatic elevation was confirmed by fluoroscopy, and the patient was diagnosed with phrenic nerve palsy.However, the physician had no idea about the cause of the ae.The physician commented that it was not related to the bwi product.No intervention required.Patient outcome of the adverse event: improved, over time, the patient's condition was improved.As of (b)(6) 2021, the patient's condition was confirmed to be normal without any issue.It was not reported extended hospitalization was required.It is life threatening; it might result in permanent impairment of a body function or permanent damage to a body structure; or it required medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

• Brand Name: THERMOCOOL SMART TOUCH SF 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12357626
• MDR Text Key: 267822890
• Report Number: 2029046-2021-01381
• 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: foreign
• Type of Report: Initial
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2022
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30532962M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GENERATOR
• Patient Outcome(s): Life Threatening