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

Model Number D134805

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

Patient Problem Dyspnea (1816)

Event Date 08/30/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that the product is not available as the customer is retaining the product.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.A manufacturing record evaluation was performed for the finished device 30208852l number, and no internal actions related to the complaint was found during the review.Manufacturer's ref.No: (b)(4).

Event Description

During a clinical trial, sponsored by biosense webster, inc., it was reported that a (b)(6) female patient underwent a pulmonary vein isolation (pvi) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter on (b)(6) 2019 and developed shortness of breath (sob).On post-procedure day 2 ((b)(6) 2019), the patient developed sob.An unspecified medication was administered.Extended hospitalization was required.The issue was resolved, and the patient was discharged.The principal investigator assessed this event as moderate in severity, serious, not related to the study device (visitag surpoint epu), not related to the study catheter, not related to the bwi non-investigational device and probable index procedure related.In the opinion of the investigator this event was expected.

Manufacturer Narrative

After further review on november 8, 2019, this event under this product ¿thermocool® smart touch¿ electrophysiology catheter¿ was reassessed from a ¿serious injury¿ to concomitant product which is ¿not reportable¿.However, since it has already been reported to the fda, any additional updates received will continue to be reported.Therefore, this product was added to the concomitant medical products and therapy dates section.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Initially it was reported that an unspecified medication was administered.Additional information was received on august 17, 2020 stating no intervention was required.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: 9079656
• MDR Text Key: 161356717
• Report Number: 2029046-2019-03649
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30208852L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO3 EXTERNAL REFPATCH 6PACK; CBL, 34 HYP/34 LEMO, 10'; THMCL SMTCH SF BID, TC, D-F; VISITAG SURPOINT EPU
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 142