MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO® NAV ECO CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D134901

Device Problems Entrapment of Device (1212); Device Contamination with Body Fluid (2317); Patient Device Interaction Problem (4001)

Patient Problem Rupture (2208)

Event Date 01/16/2023

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone : (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Biosense webster manufacturer's reference number (b)(4) has three reports: (1) mfr # 2029046-2023-00277 for product code d134801 (thermocool® smart touch® sf bi-directional navigation catheter) (2) mfr # 2029046-2023-00279 for product code d134801 (thermocool® smart touch® sf bi-directional navigation catheter) (3) mfr # 2029046-2023-00281 for product code d134901 (lasso® nav eco catheter).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with two thermocool® smart touch® sf bi-directional navigation catheters and a lasso® nav eco catheter and suffered cardiac tamponade requiring a pericardiocentesis.It was reported that after ablation was conducted several times after insertion to the patient¿s body, sensor error (106) occurred.Pericardial fluid was accumulated after the procedure, about 300 cc of drainage was performed.Also, the tricuspid regurgitation (tr) value after the procedure seemed to be high.The biosense webster representative had explained that the ring catheter is contraindicated for the ventricles to the physician, but the physician used the catheter at the physician¿s discretion.The tricuspid valve was caught during right ventricular outflow tract (rvot) mapping, and the catheter could be removed at that time, but some tissue was attached to the removed ring catheter.The tissue was sent for biopsy.Timing when complaints occurred was after the catheter was inserted into the patient¿s body, and after ablation was conducted several times, when effusion was confirmed after the procedure.The cable was changed but the issue continued.The issue was resolved by changing the catheter to another one.At the time when the patient left the room, tr value was high, the vital signs were stable, but the chordae had been destroyed.The patient had to take diuretics.No cardiac surgery has been planned.The patient was admitted to the icu.The physician's opinions on the relationship between the event and the product was that the timing of pericardial effusion is unknown.There were no abnormalities observed prior to use of the product.The patient outcome of the adverse event is improved.Valve damage occurred at mapping phase.It is unknown when cardiac tamponade occurred.The force sensor error 106 is not mdr reportable.The biological material found on the catheter is not mdr reportable.The entrapment of device is a mdr reportable product malfunction.Since the event (cardiac tamponade and cardiac valve rupture) is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Section h3.Has been updated.A manufacturing record evaluation (mre) was performed for the finished device and no internal action related to the complaint was found during the review.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.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: LASSO® NAV ECO CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16368686
• MDR Text Key: 309494325
• Report Number: 2029046-2023-00281
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009651
• UDI-Public: 10846835009651
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134901
• Device Catalogue Number: D134901
• Device Lot Number: 30827527L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2022
• 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: SOUNDSTAR ECO SMS 8F CATHETER.; THMCL SMTCH SF BID, TC, D-D.; THMCL SMTCH SF BID, TC, D-D.; UNK BRAND CABLE.; UNK BRAND CABLE.
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Female