MAUDE Adverse Event Report: BIOSENSE WEBSTER INC GENERIC THMCL SF SMTCH UNID, TC; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134700

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

Patient Problems Inflammation (1932); Cardiac Tamponade (2226)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

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.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.Since no lot number was provided, no manufacture record evaluation (mre) review could be performed.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Reports 2029046-2019-03234 are related to this same incident.Manufacture reference no: (b)(4).

Event Description

It was reported that a male patient underwent an atrial flutter (afl) ablation procedure with a thermocool® smart touch® sf bi-directional navigation (stsf) and a thermocool® smart touch® sf uni-directional navigation catheter and developed pericarditis and cardiac tamponade requiring pericardiocentesis.Initially it was reported that during the procedure it was noted that after several radio frequency applications with the stsf catheter, the catheter temperature dropped from 32c to 16c and the catheter handle was warmer than usual.The cable was exchanged without resolution.The stsf catheter was then replaced with an unknown catheter, which worked well, and the procedure was completed.After the patient left the lab, it was then noted the patient suffered pericardial effusion and pericarditis.The initial observed low temperature and warm handle was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The observed pericardial effusion and pericarditis was assessed as not mdr reportable as there was no indication that a medical and or surgical intervention was performed.It was reported that the stsf catheter was replaced by an unknown product and confirmed that the product information is not available.Therefore a generic stsf device will be used in order to address the patient consequences under both products, as two different catheters were used during the case.Clarification was then received on 5/13/2019, indicating the patient actually had cardiac tamponade in addition to the pericarditis.Thereafter, pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardial space.Extended hospitalization was required as a result of the adverse event.The patient¿s outcome was fully recovered with no residual effects and the physician¿s opinion regarding the cause of the adverse event is that it was patient condition-related.Transseptal puncture was performed during the case.The irrigation was set at 2ml/min during mapping, and 15ml/min during the ablation phase.No error messages were observed on any biosense webster inc.(bwi) equipment during the case.The catheter was zeroed after the initial warm-up phase post catheter connection to the carto® 3 patient interface.The carto 3 system did not indicate to re-zero the catheter.The issue of cardiac tamponade and pericarditis has been assessed as mdr reportable as the adverse event required medical treatment.The awareness date has been reset to 5/13/2019.

• Brand Name: GENERIC THMCL SF SMTCH UNID, TC
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8677067
• MDR Text Key: 147305316
• Report Number: 2029046-2019-03235
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention