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

Catalog Number D134805

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

Patient Problem Cardiac Tamponade (2226)

Event Date 07/19/2019

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.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.(b)(6).Manufacturer's reference number: (b)(4).

Event Description

It was reported that during atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter the patient suffered cardiac tamponade requiring pericardiocentesis.Two hours into the procedure, after pulmonary vein isolation and cavotricuspid line were performed, pericardial effusion was discovered.There were no error messages observed on biosense webster equipment during the procedure.There was no report of steam pop.It is not clear if the patient underwent thoracotomy.Blood pressure was stable, and the patient was stable after drainage.There is no further information about the hospitalization.The physician¿s commented that he/she thinks it is caused by a technical problem, not a defective catheter.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

Originally the lot number was reported as ¿unknown¿.Additional information was received on december 6, 2019 providing the lot number of 30213020m.Therefore, device manufacture date and expiration date were populated.A manufacturing record evaluation was performed for the finished device 30213020m number, and no internal actions related to the complaint was found during the review.Method codes "analysis of production records".Additional information was provided on the event on december 25, 2019.Pericardiocentesis was performed.The patient¿s condition is improved.Later the caller stated that per physician's opinion this event was a consequence of the procedure.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: 9366759
• MDR Text Key: 167768304
• Report Number: 2029046-2019-03926
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30213020M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/23/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention