MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THMCL SMTCH SF BID, TC, F-J; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134804

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

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 09/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.  a manufacturing record evaluation was performed for the finished device 30240592m number, and no internal actions related to the complaint was found during the review.Manufacturer's reference # (b)(4).

Event Description

It was reported that a (b)(6) male patient underwent cardiac ablation with a thermocool® smart touch® sf bi-directional navigation catheter.On (b)(6) 2019, post-procedure day 1, the patient suffered bleeding from the left access site in the groin, requiring surgical intervention.No extended hospitalization was required.An unspecified medication was administered, and the issue resolved.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 catheters, not related to biosense webster, inc.Non-investigational device and causally related to the study procedure.In the opinion of the investigator, this event was expected.No biosense webster, inc.Product deficiencies were reported.

Manufacturer Narrative

After further review on (b)(6)2019 , this event under this product ¿thermocool® smart touch® sf bi-directional navigation 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 d11.Concomitant medical products and therapy dates section.On (b)(6)2019 , it was noticed that the concomitant product was inadvertently omitted from the 3500a initial mdr submitted to fda on 10/5/2019.The product has now been added to section d11.Concomitant med products.Manufacturer's reference # (b)(4).

• Brand Name: THMCL SMTCH SF BID, TC, F-J
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9160087
• MDR Text Key: 161515978
• Report Number: 2029046-2019-03729
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2020
• Device Catalogue Number: D134804
• Device Lot Number: 30240592M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; CARTO3 EXTERNAL REFPATCH 6PACK; CBL, 34 HYP/34 LEMO, 10'; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; THMCL SMTCH SF BID, TC, F-J
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 88